Chondral Lesion Plus Partial Medial Meniscectomy
Conditions
Keywords
Articular cartilage, Cartilage lesion, Cartilage defect, Radiofrequency, Debridement, Cartilage, Coblation, Knee, Meniscus, Meniscectomy, MR imaging, Mechanical debridement, Mechanical shaver, Torn meniscus, Arthroscopic knee surgery, Damaged cartilage
Brief summary
The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.
Detailed description
This is a non-inferiority, prospective, double blinded, multi-center, randomized, controlled, adaptive study design with enrollment of 82 randomized subjects at up to 13 study sites. Study duration will be until the last subject enrolled reaches 104 weeks post-operative. The study will be comprised of two parts: Part I: Part I will require all Investigators perform 1 to 3 procedures using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Investigators must be qualified by training to perform procedures prior to use of either study device. This purpose of Part I will be to minimize variability with the recommended directions for use established in the instructions for use (IFU). Part I subjects will be followed per protocol follow-up requirements, and will be included in the safety population only. These subjects will be additive (to the safety population) to the 82 randomized subjects planned as part of the primary evaluation in Part II. Part II: Part II will consist of 82 randomized subjects. Each Investigator may initiate enrollment of subjects in this part of the study following completion of Part I requirements. The Part II study implements a randomized adaptive study design, whereby an interim analysis will be conducted for sample size re-assessment. There is no intention of reducing the sample size as a result of this interim analysis; however, the sample size may be increased to either establish the non-inferiority and/or may be increased sufficiently to establish superiority depending on the results of the interim analysis.
Interventions
DEVICEMechanical Debridement
mechanical shaver that removes areas of damaged tissue
DEVICERF-Based Debridement
Electrical energy that removes areas of damaged tissue (Coblation®)
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects MUST meet ALL of the following criteria to be included in the study: 1. Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation 2. Is male or non pregnant female ≥ eighteen (18) years of age 3. MRI within 9 months of enrollment into this study confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy (as determined by the Investigator) 4. Must present with pain in the index knee of moderate or severe (\> 30 mm) as measured by the VAS 5. Must be able to understand English (written and oral) 6. Must be available to come to all study related visits and is physically and mentally willing and able to comply with all post-operative evaluations 7. Must be in general good health (as determined by the Investigator) based on screening assessments and medical history Intra-operative Inclusion Criteria Subjects MUST meet ALL of the following criteria to be included in the study: 1\. Arthroscopic confirmation of a lesion requiring treatment meeting the following parameters: 1. Single, treatable chondral lesion, localized to the medial femoral condyle, 2. ICRS Grade 2 with widely displaceable fibrillation or flaps or Grade 3A, 3. \< 4cm2 in size
Exclusion criteria
Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria: 1. Body Mass Index (BMI) \> 40 or index joint pain is due to BMI (as determined by Investigator) 2. Requires bilateral knee surgery 3. Any of the following conditions: 1. active joint infections 2. is immunocompromised, has Sickle Cell disease, has a primary bone disease (e.g., Paget's disease) or disorders that may adversely affect the healing process, or is terminally ill 3. inflammatory rheumatoid arthritis or other systemic inflammatory arthritis (i.e., gout) 4. metastatic and/or neoplastic disease 5. infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis) 6. coagulation disorder or patient is receiving anti-coagulants 7. documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within 12 months of enrollment into this study 8. diagnosed with a behavioral condition which could affect their ability to accurately comply with the study (e.g. developmental delay, attention deficit disorder, and autism) 4. Any of the following conditions in the index limb or joint: 1. Grade III or greater osteoarthritis as determined by AP radiograph (Kellgren-Lawrence classification) 2. systemic steroid therapy or steroid intra-articular therapy within 4 weeks of enrollment into this study 3. intra-articular viscosupplementation within 3 months of enrollment into this study 4. osteomyelitis, septicemia, or other infections that may spread to other areas of the body 5. fractures, osteocysts or osteolysis 6. recurrent patellar instability (e.g., subluxation or dislocation) 7. severe Varus or Valgus knee deformities (as determined by Investigator) 8. symptomatic tear of the lateral meniscus 9. avascular necrosis 10. synovial disorders (e.g., pigmented villanodular synovitis) 11. previous total or partial meniscectomy 12. requires reconstruction or replacement of medial or lateral meniscus 13. knee instability, malalignment, or patellar tracking dysfunction 14. prior treatment for cartilage repair, including but not limited to ACI, Mosaicplasty and/or marrow stimulation procedures 15. prior knee tendon and/or ligament repair or patellar surgery within 6 months of enrollment into this study 5. Any of the following conditions in the contralateral limb or joint: 1. greater than minimal abnormality as shown by clinical exam and/or imaging 2. scheduled or to be scheduled for surgery over the course of this study 3. involvement causing abnormal ambulation and non-compliance with post-operative rehabilitation guideline 6. The subject has implanted metallic devices (insulin pumps, nerve stimulators, etc), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the knee 7. The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the index knee 8. Receiving prescription narcotic pain medication for conditions unrelated to the index knee condition 9. Cardiac pacemaker or other electronic implant(s) 10. Pregnant and/or intending to become pregnant during this study period 11. Participated in a clinical study within 30 days of enrollment into this study, or who is currently participating in another clinical study. 12. Is a prisoner, or is known or suspected to be transient 13. Is involved with Worker's Compensation unrelated to the index knee 14. Is involved with health-related litigation Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative | Postop Week 52 | The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living \[ADL\], Function in Sport and Recreation \[Sport/Rec\] and knee related Quality of Life \[QoL\]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method). Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems. KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET | Knee examination with respect to generalized laxity (tight, normal, lax) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100 |
| Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET | Knee examination with respect to alignment (obvious varus, normal, obvious valgus) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100 |
| Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET | Knee examination with respect to patella position (obvious baja, normal, obvious alta) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100 |
| Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET | Knee examination with respect to patella subluxation/ dislocation (centered, subluxable, subluxed and dislocated) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100 |
| Change in KOOS Scores From Baseline | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET | The scores of 5 subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS) (i.e., pain, other symptoms, function in daily living \[ADL\], function in sport and recreation \[Sport/Rec\], and knee-related Quality of Life \[QoL\]) change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the KOOS subscale score at each of the scheduled post-operative visits. Each subscale response was based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). A score of 100 indicated no problems and a score of 0 indicated extreme problems. The KOOS calculations were calculated as follows: Individual KOOS subscale scores = 100 - (mean of the observed items within the subscale x100) / 4 Change from Baseline in KOOS at Week (x) or Day (x) = KOOS at Week (x) or Day (x) - KOOS at Baseline |
| Subject Satisfaction Postoperatively at Weeks 52 and 104 | Postop Weeks 52 and 104/ET | Subjects were questioned regarding their satisfaction with study treatment for knee pain. |
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET) | The scores of three domains of IKDC Subjective Knee Evaluation Form (i.e., \[1\] symptoms, including pain, stiffness, swelling, locking/catching, and giving way; \[2\] sports and daily activities; and \[3\] current knee function) at Baseline, each of scheduled post-operative visits and changes from Baseline were summarized descriptively by treatment group. Change from Baseline in IKDC = IKDC at Baseline + Pseudo-site + Treatment + Treatment\*Pseudo-site The IKDC score was interpreted by summing the scores for the individual questions and then transforming the score to a scale that ranged from 0 to 100: Individual domain IKDC score = \[raw score - lowest possible score/range of scores\] x 100 The IKDC total score was interpreted as higher scores = higher function, lower scores = lower function. Treatment\*Pseudo-site interaction term was non-significant at the 0.05 level and hence was dropped from the statistical method. |
| Change in Visual Analog Scale (VAS) Scores From Baseline | Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET | The VAS knee pain scores were assessed at Baseline, post-operative visits (Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET) and change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the VAS knee pain score at each of the scheduled post-operative visits. The model had change in VAS knee pain as the response variable and treatment, Baseline VAS knee pain, site, treatment-by-site interaction, lesion-grade, and lesion-grade interaction as independent variables. Scores ranged from 0 to 100 with pain intensity measured as none, mild, moderate, or severe: No pain (0-4) Mild pain (5-44) Moderate pain (45-74) Severe pain (75-100) VAS scores were calculated as: Change in VAS knee pain score from Baseline at Week (x) or Day (x) = VAS knee pain at Week (x) or Day (x) - VAS knee pain at Baseline |
| Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET | SF-12 PCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52 and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 PCS scores at each of the scheduled post-operative visits. The model had change in SF-12 PCS score as the response variable and treatment, Baseline SF-12 PCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables. Results were expressed as the PCS. Scores could range from 0 (the worst) to 100 (the best). SF-12 scores for PCS were calculated as: Change in SF-12 PCS score from Baseline at Week (x) = PCS score at Week (x) - PCS score at Baseline |
| Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET | SF-12 MCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52, and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 MCS scores at each of the scheduled post-operative visits. The model had change in SF-12 MCS score as the response variable and treatment, Baseline SF-12 MCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables. Results were expressed as the MCS. Scores could range from 0 (the worst) to 100 (the best). SF-12 scores for MCS were calculated as: Change in SF-12 MCS score from Baseline at Week (x) = MCS score at Week (x) - MCS score at Baseline |
| Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET | The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses. Each individual category calculated a score of between -1 and +1. A score of -1 showed the worst improvement and a score of +1 showed the most improvement. Summary total scores for EQ-5D-5L were calculated as: Change in EQ-5D-5L score from Baseline at Week (x) or Day (x) = EQ-5D-5L score at Week (x) or Day (x) - EQ-5D-5L score at Baseline |
| Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET | The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses. The EQ-VAS score ranged from 0 to 100 with higher scores representing better health and lower scores representing worse health. Summary total scores for EQ-VAS were calculated as: Change in EQ-VAS score from Baseline at Week (x) or Day (x) = EQ-VAS score at Week (x) or Day (x) - EQ-VAS score at Baseline |
| Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET | MRIs were obtained post-operatively at Day 10, obtained during the time period of Day 10 through Week 52, and again obtained during the time period of Week 52 through Week 104/ET). The images were evaluated using ICRS assessments of chondral lesions to determine the percentage of change in cartilage lesions over time post-operatively. ICRS partial-thickness chondral lesion assessment scores: Low-grade defect = less than 50% High-grade defect = 50% to 99% |
Countries
United States
Participant flow
Recruitment details
There were 148 subjects who initially signed a consent form, although 72 subjects withdrew consent prior to starting the study. This resulted in only 76 subjects actually starting the study and proceeding with study treatment.
Pre-assignment details
Part I required all qualified investigators to perform 1 to 3 procedures using the study devices for the purpose of minimizing variability with the recommended directions for use established in the instructions for use. Part I subjects were to be included in the safety population only.
Participants by arm
| Arm | Count |
|---|---|
| Part I Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only. | 19 |
| Part II: RF-based Debridement Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself. | 28 |
| Part II: Mechanical Debridement Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. | 29 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Early study termination | 0 | 6 | 5 |
| Overall Study | Incomplete data entry by sites | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 3 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Unable to return for follow-up visits | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 4 |
Baseline characteristics
| Characteristic | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 8.15 | 59.9 years STANDARD_DEVIATION 7.22 | 58.0 years STANDARD_DEVIATION 9.76 | 57.7 years STANDARD_DEVIATION 8.68 |
| Age, Customized Age of Subjects <40 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Customized Age of Subjects ≥40 years | 18 Participants | 28 Participants | 28 Participants | 74 Participants |
| BMI | 28.4 kg/m^2 STANDARD_DEVIATION 3.02 | 29.9 kg/m^2 STANDARD_DEVIATION 3.41 | 29.0 kg/m^2 STANDARD_DEVIATION 4.02 | 29.2 kg/m^2 STANDARD_DEVIATION 3.57 |
| Duration (days) since onset of symptoms for index knee Acute: ≤30 days | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Duration (days) since onset of symptoms for index knee Chronic: >6 months | 11 Participants | 9 Participants | 6 Participants | 26 Participants |
| Duration (days) since onset of symptoms for index knee Missing | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Duration (days) since onset of symptoms for index knee Subacute: 31 days - 6 months | 8 Participants | 16 Participants | 20 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 26 Participants | 25 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Knee Alignment Normal | 18 Participants | 26 Participants | 29 Participants | 73 Participants |
| Knee Alignment Valgus malalignment | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Knee Alignment Varus malalignment | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Narrowest width of meniscal rim post-operatively (radial measurement of meniscus post resection) 0 - 3º | 5 Participants | 10 Participants | 7 Participants | 22 Participants |
| Narrowest width of meniscal rim post-operatively (radial measurement of meniscus post resection) >3º | 12 Participants | 18 Participants | 22 Participants | 52 Participants |
| Narrowest width of meniscal rim post-operatively (radial measurement of meniscus post resection) Missing | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 27 Participants | 29 Participants | 73 Participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 11 Participants | 32 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 18 Participants | 44 Participants |
| Total pre-debridement lesion size >2-4 cm^2 | 4 Participants | 9 Participants | 6 Participants | 19 Participants |
| Total pre-debridement lesion size ≤2 cm^2 | 13 Participants | 19 Participants | 23 Participants | 55 Participants |
| Total pre-debridement lesion size Missing | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 13 / 19 | 26 / 28 | 19 / 29 |
| serious Total, serious adverse events | 1 / 19 | 2 / 28 | 1 / 29 |
Outcome results
Primary
Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative
The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living \[ADL\], Function in Sport and Recreation \[Sport/Rec\] and knee related Quality of Life \[QoL\]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method). Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems. KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4)
Time frame: Postop Week 52
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part II: RF-based Debridement | Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative | 31.94 score on a scale | Standard Error 3.991 |
| Part II: Mechanical Debridement | Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative | 39.36 score on a scale | Standard Error 4.21 |
Comparison: An ANCOVA model was used to compare the difference in the devices for change from Baseline in the KOOS at Week 52. KOOS was derived as the average of five subscale scores. LOCF imputation was considered for missing value. One-sided 97.5% confidence interval (CI) for treatment difference (Study-Control) was to be used for determining non-inferiority/superiority of the study device.p-value: >0.05ANCOVA
Secondary
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
SF-12 PCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52 and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 PCS scores at each of the scheduled post-operative visits. The model had change in SF-12 PCS score as the response variable and treatment, Baseline SF-12 PCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables. Results were expressed as the PCS. Scores could range from 0 (the worst) to 100 (the best). SF-12 scores for PCS were calculated as: Change in SF-12 PCS score from Baseline at Week (x) = PCS score at Week (x) - PCS score at Baseline
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the SF-12 questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 6 PCS (Change from Baseline) | 8.2 score on a scale | Standard Deviation 12.62 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 36 PCS | 46.8 score on a scale | Standard Deviation 11.49 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 12 PCS (Change from Baseline) | 13.4 score on a scale | Standard Deviation 13.14 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 36 PCS (Change from Baseline) | 9.3 score on a scale | Standard Deviation 13.81 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 6 PCS | 45.1 score on a scale | Standard Deviation 9.14 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 52 PCS | 48.9 score on a scale | Standard Deviation 10.24 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 24 PCS | 48.5 score on a scale | Standard Deviation 9.6 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 52 PCS (Change from Baseline) | 11.6 score on a scale | Standard Deviation 10.99 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 12 PCS | 50.0 score on a scale | Standard Deviation 7.87 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 104/ET PCS | 51.9 score on a scale | Standard Deviation 6.96 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 24 PCS (Change from Baseline) | 11.1 score on a scale | Standard Deviation 13.14 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 104/ET PCS (Change from Baseline) | 14.1 score on a scale | Standard Deviation 11.02 |
| Part II: RF-based Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Baseline PCS | 36.5 score on a scale | Standard Deviation 10.65 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 104/ET PCS (Change from Baseline) | 15.3 score on a scale | Standard Deviation 11.42 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Baseline PCS | 38.6 score on a scale | Standard Deviation 9.63 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 6 PCS | 46.6 score on a scale | Standard Deviation 8.27 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 6 PCS (Change from Baseline) | 6.7 score on a scale | Standard Deviation 9.31 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 12 PCS | 46.6 score on a scale | Standard Deviation 8.27 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 12 PCS (Change from Baseline) | 9.4 score on a scale | Standard Deviation 10.49 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 24 PCS | 50.2 score on a scale | Standard Deviation 8.19 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 24 PCS (Change from Baseline) | 11.6 score on a scale | Standard Deviation 11.12 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 36 PCS | 52.5 score on a scale | Standard Deviation 6.98 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 36 PCS (Change from Baseline) | 13.1 score on a scale | Standard Deviation 10.43 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 52 PCS | 52.5 score on a scale | Standard Deviation 8.72 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 52 PCS (Change from Baseline) | 14.6 score on a scale | Standard Deviation 11.55 |
| Part II: Mechanical Debridement | Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score | Week 104/ET PCS | 51.6 score on a scale | Standard Deviation 8.35 |
Secondary
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses. The EQ-VAS score ranged from 0 to 100 with higher scores representing better health and lower scores representing worse health. Summary total scores for EQ-VAS were calculated as: Change in EQ-VAS score from Baseline at Week (x) or Day (x) = EQ-VAS score at Week (x) or Day (x) - EQ-VAS score at Baseline
Time frame: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the EQ-VAS questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 104/ET (Change from Baseline) | 9.2 score on a scale | Standard Deviation 13.04 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | EQ-VAS Summary Total Score (Baseline) | 74.9 score on a scale | Standard Deviation 21.7 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Day 10 | 80.7 score on a scale | Standard Deviation 16.85 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Day 10 (Change from Baseline) | 5.8 score on a scale | Standard Deviation 18.42 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 6 | 84.0 score on a scale | Standard Deviation 13.99 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 6 (Change from Baseline) | 10.5 score on a scale | Standard Deviation 14.82 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 12 | 84.6 score on a scale | Standard Deviation 14.35 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 12 (Change from Baseline) | 10.8 score on a scale | Standard Deviation 13.11 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 24 | 87.3 score on a scale | Standard Deviation 12.97 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 24 (Change from Baseline) | 13.3 score on a scale | Standard Deviation 16.09 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 36 | 84.7 score on a scale | Standard Deviation 12.97 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 36 (Change from Baseline) | 13.3 score on a scale | Standard Deviation 16.09 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 52 | 84.1 score on a scale | Standard Deviation 18.5 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 52 (Change from Baseline) | 8.6 score on a scale | Standard Deviation 18.55 |
| Part II: RF-based Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 104/ET | 87.1 score on a scale | Standard Deviation 12.96 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 104/ET (Change from Baseline) | 14.9 score on a scale | Standard Deviation 13.27 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 12 | 90.1 score on a scale | Standard Deviation 7.06 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 24 | 88.4 score on a scale | Standard Deviation 10.98 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | EQ-VAS Summary Total Score (Baseline) | 76.3 score on a scale | Standard Deviation 17.9 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 52 | 90.2 score on a scale | Standard Deviation 8.6 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Day 10 | 88.0 score on a scale | Standard Deviation 8.87 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 24 (Change from Baseline) | 14.0 score on a scale | Standard Deviation 16.63 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Day 10 (Change from Baseline) | 11.7 score on a scale | Standard Deviation 16.8 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 104/ET | 90.3 score on a scale | Standard Deviation 11.55 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 6 | 89.5 score on a scale | Standard Deviation 7.41 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 36 | 91.0 score on a scale | Standard Deviation 6.01 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 6 (Change from Baseline) | 14.1 score on a scale | Standard Deviation 17.87 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 52 (Change from Baseline) | 15.1 score on a scale | Standard Deviation 17.24 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 36 (Change from Baseline) | 15.0 score on a scale | Standard Deviation 17.81 |
| Part II: Mechanical Debridement | Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score) | Week 12 (Change from Baseline) | 14.3 score on a scale | Standard Deviation 18.55 |
Secondary
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses. Each individual category calculated a score of between -1 and +1. A score of -1 showed the worst improvement and a score of +1 showed the most improvement. Summary total scores for EQ-5D-5L were calculated as: Change in EQ-5D-5L score from Baseline at Week (x) or Day (x) = EQ-5D-5L score at Week (x) or Day (x) - EQ-5D-5L score at Baseline
Time frame: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the EQ-5D-5L questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 6 | 0.791 units on a scale | Standard Deviation 0.1528 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 24 (Change from Baseline) | 0.100 units on a scale | Standard Deviation 0.1436 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | EQ-5D-5L Summary Total Score (Baseline) | 0.714 units on a scale | Standard Deviation 0.1503 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 36 | 0.806 units on a scale | Standard Deviation 0.165 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 6 (Change from Baseline) | 0.083 units on a scale | Standard Deviation 0.108 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 36 (Change from Baseline) | 0.096 units on a scale | Standard Deviation 0.1524 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Day 10 (Change from Baseline) | 0.024 units on a scale | Standard Deviation 0.1331 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 52 | 0.835 units on a scale | Standard Deviation 0.195 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 12 (Change from Baseline) | 0.116 units on a scale | Standard Deviation 0.1182 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 52 (Change from Baseline) | 0.135 units on a scale | Standard Deviation 0.1502 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Day 10 | 0.738 units on a scale | Standard Deviation 0.1309 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 104/ET | 0.843 units on a scale | Standard Deviation 0.129 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 24 | 0.814 units on a scale | Standard Deviation 0.1473 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 104/ET (Change from Baseline) | 0.106 units on a scale | Standard Deviation 0.1381 |
| Part II: RF-based Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 12 | 0.823 units on a scale | Standard Deviation 0.1614 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 104/ET (Change from Baseline) | 0.167 units on a scale | Standard Deviation 0.147 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 6 (Change from Baseline) | 0.081 units on a scale | Standard Deviation 0.1318 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | EQ-5D-5L Summary Total Score (Baseline) | 0.745 units on a scale | Standard Deviation 0.91 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Day 10 | 0.788 units on a scale | Standard Deviation 0.0967 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Day 10 (Change from Baseline) | 0.043 units on a scale | Standard Deviation 0.1151 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 6 | 0.825 units on a scale | Standard Deviation 0.0999 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 12 | 0.854 units on a scale | Standard Deviation 0.1145 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 12 (Change from Baseline) | 0.094 units on a scale | Standard Deviation 0.1137 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 24 | 0.854 units on a scale | Standard Deviation 0.1047 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 24 (Change from Baseline) | 0.105 units on a scale | Standard Deviation 0.1269 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 36 | 0.914 units on a scale | Standard Deviation 0.0895 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 36 (Change from Baseline) | 0.143 units on a scale | Standard Deviation 0.0743 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 52 | 0.911 units on a scale | Standard Deviation 0.1267 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 52 (Change from Baseline) | 0.162 units on a scale | Standard Deviation 0.1362 |
| Part II: Mechanical Debridement | Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score) | Week 104/ET | 0.906 units on a scale | Standard Deviation 0.1298 |
Secondary
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
The scores of three domains of IKDC Subjective Knee Evaluation Form (i.e., \[1\] symptoms, including pain, stiffness, swelling, locking/catching, and giving way; \[2\] sports and daily activities; and \[3\] current knee function) at Baseline, each of scheduled post-operative visits and changes from Baseline were summarized descriptively by treatment group. Change from Baseline in IKDC = IKDC at Baseline + Pseudo-site + Treatment + Treatment\*Pseudo-site The IKDC score was interpreted by summing the scores for the individual questions and then transforming the score to a scale that ranged from 0 to 100: Individual domain IKDC score = \[raw score - lowest possible score/range of scores\] x 100 The IKDC total score was interpreted as higher scores = higher function, lower scores = lower function. Treatment\*Pseudo-site interaction term was non-significant at the 0.05 level and hence was dropped from the statistical method.
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET)
Population: Not all participants completed the IKDC score questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 6 (Change from Baseline) | 21.0 score on a scale | Standard Deviation 13.3 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 36 | 70.2 score on a scale | Standard Deviation 25.61 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 12 (Change from Baseline) | 30.6 score on a scale | Standard Deviation 19.57 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 36 (Change from Baseline) | 30.6 score on a scale | Standard Deviation 22.05 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 6 | 60.7 score on a scale | Standard Deviation 15.42 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 52 | 75.7 score on a scale | Standard Deviation 25.61 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 24 | 72.9 score on a scale | Standard Deviation 21.21 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 52 (Change from Baseline) | 30.6 score on a scale | Standard Deviation 22.05 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 12 | 69.8 score on a scale | Standard Deviation 20.63 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 104/ET | 77.2 score on a scale | Standard Deviation 20.63 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 24 (Change from Baseline) | 33.4 score on a scale | Standard Deviation 17.71 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 104/ET (Change from Baseline) | 36.8 score on a scale | Standard Deviation 21.84 |
| Part II: RF-based Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | IKDC Summary Total Scores (Baseline) | 39.4 score on a scale | Standard Deviation 14.56 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 104/ET (Change from Baseline) | 45.8 score on a scale | Standard Deviation 20.46 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | IKDC Summary Total Scores (Baseline) | 37.3 score on a scale | Standard Deviation 14.4 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 6 | 64.4 score on a scale | Standard Deviation 16.39 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 6 (Change from Baseline) | 27.0 score on a scale | Standard Deviation 22.17 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 12 | 70.3 score on a scale | Standard Deviation 20.24 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 12 (Change from Baseline) | 33.1 score on a scale | Standard Deviation 20.55 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 24 | 70.2 score on a scale | Standard Deviation 17.31 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 24 (Change from Baseline) | 32.7 score on a scale | Standard Deviation 21.07 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 36 | 78.8 score on a scale | Standard Deviation 15.5 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 36 (Change from Baseline) | 41.1 score on a scale | Standard Deviation 18.25 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 52 | 80.4 score on a scale | Standard Deviation 20.26 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 52 (Change from Baseline) | 45.3 score on a scale | Standard Deviation 21.2 |
| Part II: Mechanical Debridement | Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline. | Week 104/ET | 80.0 score on a scale | Standard Deviation 21.66 |
Secondary
Change in KOOS Scores From Baseline
The scores of 5 subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS) (i.e., pain, other symptoms, function in daily living \[ADL\], function in sport and recreation \[Sport/Rec\], and knee-related Quality of Life \[QoL\]) change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the KOOS subscale score at each of the scheduled post-operative visits. Each subscale response was based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). A score of 100 indicated no problems and a score of 0 indicated extreme problems. The KOOS calculations were calculated as follows: Individual KOOS subscale scores = 100 - (mean of the observed items within the subscale x100) / 4 Change from Baseline in KOOS at Week (x) or Day (x) = KOOS at Week (x) or Day (x) - KOOS at Baseline
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the KOOS questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 104/ET | 83.9 score on a scale | Standard Deviation 17.71 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 24 (Change from Baseline) | 34.9 score on a scale | Standard Deviation 32.46 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 104/ET (Change from Baseline) | 44.2 score on a scale | Standard Deviation 25.9 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 12 | 66.5 score on a scale | Standard Deviation 24.13 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 12 (Change from Baseline) | 39.0 score on a scale | Standard Deviation 27.56 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 6 | 67.0 score on a scale | Standard Deviation 19.77 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Baseline | 46.2 score on a scale | Standard Deviation 17.26 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 6 | 70.9 score on a scale | Standard Deviation 19.62 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 6 (Change from Baseline) | 25.3 score on a scale | Standard Deviation 16.92 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 12 | 80.6 score on a scale | Standard Deviation 20.05 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 12 (Change from Baseline) | 35.8 score on a scale | Standard Deviation 21.92 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 24 | 78.5 score on a scale | Standard Deviation 22.15 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 24 (Change from Baseline) | 32.5 score on a scale | Standard Deviation 21.91 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 36 | 78.7 score on a scale | Standard Deviation 25.98 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 36 (Change from Baseline) | 29.6 score on a scale | Standard Deviation 25.92 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 52 | 81.5 score on a scale | Standard Deviation 24.91 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 52 (Change from Baseline) | 35.8 score on a scale | Standard Deviation 21.98 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 104/ET | 88.3 score on a scale | Standard Deviation 15.18 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Pain - Week 104/ET (Change from Baseline) | 38.9 score on a scale | Standard Deviation 21.5 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Baseline | 58.4 score on a scale | Standard Deviation 20.72 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 6 | 73.5 score on a scale | Standard Deviation 17.64 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 6 (Change from Baseline) | 16.0 score on a scale | Standard Deviation 20.76 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 36 | 74.1 score on a scale | Standard Deviation 23.17 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 12 | 81.3 score on a scale | Standard Deviation 19.73 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 12 (Change from Baseline) | 25.0 score on a scale | Standard Deviation 25.63 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 24 | 79.8 score on a scale | Standard Deviation 20.22 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 24 (Change from Baseline) | 21.9 score on a scale | Standard Deviation 22.55 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 36 (Change from Baseline) | 17.0 score on a scale | Standard Deviation 24.9 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 52 | 78.7 score on a scale | Standard Deviation 24.12 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 52 (Change from Baseline) | 19.8 score on a scale | Standard Deviation 26.33 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Other Symptoms -Week 104/ET (Change from Baseline) | 24.5 score on a scale | Standard Deviation 23.53 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Baseline | 53.5 score on a scale | Standard Deviation 21.48 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 6 | 76.6 score on a scale | Standard Deviation 21.09 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 6 (Change from Baseline) | 23.3 score on a scale | Standard Deviation 18.43 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 12 | 84.1 score on a scale | Standard Deviation 21.02 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 12 (Change from Baseline) | 32.0 score on a scale | Standard Deviation 24.33 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 24 | 84.6 score on a scale | Standard Deviation 20.88 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 24 (Change from Baseline) | 31.1 score on a scale | Standard Deviation 24.53 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 36 | 78.7 score on a scale | Standard Deviation 23.58 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 36 (Change from Baseline) | 24.3 score on a scale | Standard Deviation 24.32 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 52 | 83.6 score on a scale | Standard Deviation 23.85 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 52 (Change from Baseline) | 30.4 score on a scale | Standard Deviation 24.06 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 104/ET | 89.0 score on a scale | Standard Deviation 16.72 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | ADLs - Week 104/ET (Change from Baseline) | 32.6 score on a scale | Standard Deviation 24.53 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Baseline | 29.9 score on a scale | Standard Deviation 22.68 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 6 | 54.1 score on a scale | Standard Deviation 25.87 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 6 (Change from Baseline) | 23.1 score on a scale | Standard Deviation 27 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 12 | 72.0 score on a scale | Standard Deviation 24.66 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 12 (Change from Baseline) | 42.3 score on a scale | Standard Deviation 30.24 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 24 | 65.6 score on a scale | Standard Deviation 30.59 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 36 | 63.0 score on a scale | Standard Deviation 33.02 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 36 (Change from Baseline) | 32.8 score on a scale | Standard Deviation 35.6 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 52 | 73.0 score on a scale | Standard Deviation 30.28 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 52 (Change from Baseline) | 41.4 score on a scale | Standard Deviation 30.56 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 104/ET | 76.0 score on a scale | Standard Deviation 26.49 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Baseline | 28.8 score on a scale | Standard Deviation 16.78 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 6 | 59.7 score on a scale | Standard Deviation 21.11 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 6 (Change from Baseline) | 31.0 score on a scale | Standard Deviation 25.09 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 24 | 67.2 score on a scale | Standard Deviation 26.98 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 24 (Change from Baseline) | 36.2 score on a scale | Standard Deviation 34.4 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 36 | 66.3 score on a scale | Standard Deviation 32.66 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 36 (Change from Baseline) | 35.9 score on a scale | Standard Deviation 31.86 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 52 | 72.5 score on a scale | Standard Deviation 28.42 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 52 (Change from Baseline) | 41.9 score on a scale | Standard Deviation 25.5 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 104/ET | 79.1 score on a scale | Standard Deviation 21.77 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | QoL - Week 104/ET (Change from Baseline) | 46.9 score on a scale | Standard Deviation 25.29 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Baseline | 43.4 score on a scale | Standard Deviation 17.82 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 6 (Change from Baseline) | 23.7 score on a scale | Standard Deviation 18.85 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 12 | 76.9 score on a scale | Standard Deviation 20.81 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 12 (Change/Baseline) | 34.8 score on a scale | Standard Deviation 23.84 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 24 | 75.1 score on a scale | Standard Deviation 22.69 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 24 (Change/Baseline) | 31.3 score on a scale | Standard Deviation 23.01 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 36 | 71.6 score on a scale | Standard Deviation 26.41 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 36 (Change/Baseline) | 27.9 score on a scale | Standard Deviation 25.78 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 52 | 77.9 score on a scale | Standard Deviation 25.41 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 52 (Change/Baseline) | 33.9 score on a scale | Standard Deviation 23.42 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 104/ET | 83.3 score on a scale | Standard Deviation 17.88 |
| Part II: RF-based Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 104/ET (Change/Baseline) | 37.4 score on a scale | Standard Deviation 21.47 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 52 (Change from Baseline) | 32.3 score on a scale | Standard Deviation 18.07 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 36 | 77.3 score on a scale | Standard Deviation 23.82 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 104/ET | 90.8 score on a scale | Standard Deviation 13.39 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 12 (Change/Baseline) | 32.3 score on a scale | Standard Deviation 21.05 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 104/ET (Change from Baseline) | 36.3 score on a scale | Standard Deviation 16.67 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 36 (Change from Baseline) | 47.4 score on a scale | Standard Deviation 25.34 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Baseline | 30.2 score on a scale | Standard Deviation 23.58 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Baseline | 50.6 score on a scale | Standard Deviation 13.1 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 104/ET (Change/Baseline) | 43.0 score on a scale | Standard Deviation 18.22 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 6 | 80.4 score on a scale | Standard Deviation 14.9 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 6 | 61.5 score on a scale | Standard Deviation 24.25 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 6 (Change from Baseline) | 29.9 score on a scale | Standard Deviation 19.66 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 52 | 75.6 score on a scale | Standard Deviation 26.59 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 12 | 82.3 score on a scale | Standard Deviation 17.23 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 6 (Change from Baseline) | 29.4 score on a scale | Standard Deviation 35.06 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 12 (Change from Baseline) | 30.3 score on a scale | Standard Deviation 19.83 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 24 | 77.8 score on a scale | Standard Deviation 15.7 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 24 | 80.4 score on a scale | Standard Deviation 15.39 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 12 | 67.0 score on a scale | Standard Deviation 25.96 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 24 (Change from Baseline) | 29.1 score on a scale | Standard Deviation 18.37 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 52 (Change from Baseline) | 47.5 score on a scale | Standard Deviation 27.01 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 36 | 89.0 score on a scale | Standard Deviation 9.55 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 12 (Change from Baseline) | 38.2 score on a scale | Standard Deviation 28.53 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 36 (Change from Baseline) | 36.8 score on a scale | Standard Deviation 12.94 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 52 | 83.7 score on a scale | Standard Deviation 19.66 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 52 | 87.6 score on a scale | Standard Deviation 18.3 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 24 | 69.3 score on a scale | Standard Deviation 22.88 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 52 (Change from Baseline) | 38.2 score on a scale | Standard Deviation 18.79 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 104/ET | 76.7 score on a scale | Standard Deviation 25.38 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 104/ET | 88.5 score on a scale | Standard Deviation 17.47 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 24 (Change from Baseline) | 40.4 score on a scale | Standard Deviation 32.68 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Pain - Week 104/ET (Change from Baseline) | 39.3 score on a scale | Standard Deviation 15.17 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 36 | 75.9 score on a scale | Standard Deviation 24.33 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Baseline | 54.7 score on a scale | Standard Deviation 16.7 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 24 (Change/Baseline) | 33.3 score on a scale | Standard Deviation 20.17 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 6 | 75.7 score on a scale | Standard Deviation 18.48 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 36 (Change from Baseline) | 45.2 score on a scale | Standard Deviation 29.38 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 6 (Change from Baseline) | 20.6 score on a scale | Standard Deviation 22.7 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 104/ET (Change from Baseline) | 50.8 score on a scale | Standard Deviation 22.89 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 52 | 78.3 score on a scale | Standard Deviation 25.09 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 12 | 83.1 score on a scale | Standard Deviation 15.14 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 104/ET | 83.9 score on a scale | Standard Deviation 19.16 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 12 (Change from Baseline) | 28.3 score on a scale | Standard Deviation 20.92 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 52 (Change from Baseline) | 51.5 score on a scale | Standard Deviation 26.81 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 24 | 80.4 score on a scale | Standard Deviation 13.99 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Baseline | 44.2 score on a scale | Standard Deviation 13.56 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 24 (Change from Baseline) | 25.2 score on a scale | Standard Deviation 18.67 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 36 | 87.7 score on a scale | Standard Deviation 10.61 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 104/ET | 77.8 score on a scale | Standard Deviation 27.88 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 36 (Change from Baseline) | 31.7 score on a scale | Standard Deviation 17.26 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Sport/Rec - Week 104/ET (Change from Baseline) | 53.8 score on a scale | Standard Deviation 29.38 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 52 | 88.0 score on a scale | Standard Deviation 14.53 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 6 | 72.7 score on a scale | Standard Deviation 14.47 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 52 (Change from Baseline) | 34.6 score on a scale | Standard Deviation 19.15 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms - Week 104/ET | 85.7 score on a scale | Standard Deviation 15.57 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Baseline | 28.4 score on a scale | Standard Deviation 14.9 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Other Symptoms -Week 104/ET (Change from Baseline) | 34.8 score on a scale | Standard Deviation 17.78 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 36 | 84.2 score on a scale | Standard Deviation 14.59 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Baseline | 57.3 score on a scale | Standard Deviation 15.31 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 6 | 59.7 score on a scale | Standard Deviation 19.79 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 6 | 86.2 score on a scale | Standard Deviation 12.18 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 6 (Change from Baseline) | 28.2 score on a scale | Standard Deviation 20.86 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 6 (Change from Baseline) | 29.6 score on a scale | Standard Deviation 16.26 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 6 (Change from Baseline) | 31.3 score on a scale | Standard Deviation 26.69 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 12 | 85.3 score on a scale | Standard Deviation 14.36 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 12 | 66.6 score on a scale | Standard Deviation 25.55 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 12 (Change from Baseline) | 27.0 score on a scale | Standard Deviation 16.16 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 12 (Change from Baseline) | 37.7 score on a scale | Standard Deviation 31 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 24 | 87.9 score on a scale | Standard Deviation 12.05 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 52 (Change/Baseline) | 40.8 score on a scale | Standard Deviation 19.97 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 24 (Change from Baseline) | 31.0 score on a scale | Standard Deviation 16.94 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 24 | 70.7 score on a scale | Standard Deviation 21.02 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 36 | 91.3 score on a scale | Standard Deviation 11.06 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 12 | 76.9 score on a scale | Standard Deviation 18.59 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 36 (Change from Baseline) | 32.0 score on a scale | Standard Deviation 14.51 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | QoL - Week 24 (Change from Baseline) | 41.0 score on a scale | Standard Deviation 24.7 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | ADLs - Week 52 | 89.2 score on a scale | Standard Deviation 17.98 |
| Part II: Mechanical Debridement | Change in KOOS Scores From Baseline | Average KOOS Score - Week 36 (Change/Baseline) | 38.6 score on a scale | Standard Deviation 16.82 |
Secondary
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
SF-12 MCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52, and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 MCS scores at each of the scheduled post-operative visits. The model had change in SF-12 MCS score as the response variable and treatment, Baseline SF-12 MCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables. Results were expressed as the MCS. Scores could range from 0 (the worst) to 100 (the best). SF-12 scores for MCS were calculated as: Change in SF-12 MCS score from Baseline at Week (x) = MCS score at Week (x) - MCS score at Baseline
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the SF-12 questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 6 MCS (Change from Baseline) | -0.1 score on a scale | Standard Deviation 8.87 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 36 MCS | 55.5 score on a scale | Standard Deviation 6.49 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 12 MCS (Change from Baseline) | 0.5 score on a scale | Standard Deviation 10.97 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 36 MCS (Change from Baseline) | 0.1 score on a scale | Standard Deviation 10.63 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 6 MCS | 55.1 score on a scale | Standard Deviation 8.44 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 52 MCS | 56.1 score on a scale | Standard Deviation 7.19 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 24 MCS | 56.6 score on a scale | Standard Deviation 5.32 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 52 MCS (Change from Baseline) | 0.6 score on a scale | Standard Deviation 9.46 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 12 MCS | 55.6 score on a scale | Standard Deviation 7.47 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 104/ET MCS | 56.1 score on a scale | Standard Deviation 5.17 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 24 MCS (Change from Baseline) | 0.7 score on a scale | Standard Deviation 10.17 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 104/ET MCS (Change from Baseline) | -0.4 score on a scale | Standard Deviation 10.84 |
| Part II: RF-based Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Baseline MCS | 55.9 score on a scale | Standard Deviation 9.98 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 104/ET MCS (Change from Baseline) | 0.1 score on a scale | Standard Deviation 10.54 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Baseline MCS | 55.1 score on a scale | Standard Deviation 9.52 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 6 MCS | 57.5 score on a scale | Standard Deviation 9.63 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 6 MCS (Change from Baseline) | 3.4 score on a scale | Standard Deviation 8.27 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 12 MCS | 55.9 score on a scale | Standard Deviation 7.75 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 12 MCS (Change from Baseline) | 1.2 score on a scale | Standard Deviation 8.05 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 24 MCS | 56.9 score on a scale | Standard Deviation 8.47 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 24 MCS (Change from Baseline) | 2.6 score on a scale | Standard Deviation 8.32 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 36 MCS | 57.1 score on a scale | Standard Deviation 4.81 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 36 MCS (Change from Baseline) | 1.8 score on a scale | Standard Deviation 7.61 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 52 MCS | 56.1 score on a scale | Standard Deviation 4.9 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 52 MCS (Change from Baseline) | 1.5 score on a scale | Standard Deviation 10.35 |
| Part II: Mechanical Debridement | Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score | Week 104/ET MCS | 55.7 score on a scale | Standard Deviation 9.91 |
Secondary
Change in Visual Analog Scale (VAS) Scores From Baseline
The VAS knee pain scores were assessed at Baseline, post-operative visits (Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET) and change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the VAS knee pain score at each of the scheduled post-operative visits. The model had change in VAS knee pain as the response variable and treatment, Baseline VAS knee pain, site, treatment-by-site interaction, lesion-grade, and lesion-grade interaction as independent variables. Scores ranged from 0 to 100 with pain intensity measured as none, mild, moderate, or severe: No pain (0-4) Mild pain (5-44) Moderate pain (45-74) Severe pain (75-100) VAS scores were calculated as: Change in VAS knee pain score from Baseline at Week (x) or Day (x) = VAS knee pain at Week (x) or Day (x) - VAS knee pain at Baseline
Time frame: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the VAS pain score questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 12 (Change from Baseline) | -45.8 units on a scale | Standard Deviation 23.98 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 52 | 11.5 units on a scale | Standard Deviation 20.08 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 24 | 15.3 units on a scale | Standard Deviation 23.88 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 6 | 17.8 units on a scale | Standard Deviation 23.05 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 24 (Change from Baseline) | -42.6 units on a scale | Standard Deviation 21.98 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Day 10 | 28.7 units on a scale | Standard Deviation 23.62 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 36 | 19.1 units on a scale | Standard Deviation 26.63 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 6 (Change from Baseline) | -38.1 units on a scale | Standard Deviation 22.75 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 36 (Change from Baseline) | -37.5 units on a scale | Standard Deviation 28.2 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 52 (Change from Baseline) | -45.8 units on a scale | Standard Deviation 20.74 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Baseline | 57.6 units on a scale | Standard Deviation 19.68 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 104/ET | 8.4 units on a scale | Standard Deviation 14.22 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 12 | 12.6 units on a scale | Standard Deviation 17.71 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 104/ET (Change from Baseline) | -47.9 units on a scale | Standard Deviation 25.92 |
| Part II: RF-based Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Day 10 (Change from Baseline) | -29.0 units on a scale | Standard Deviation 21.29 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 104/ET (Change from Baseline) | -50.7 units on a scale | Standard Deviation 30.82 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 52 | 9.3 units on a scale | Standard Deviation 19.97 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Baseline | 59.8 units on a scale | Standard Deviation 16.15 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Day 10 | 17.6 units on a scale | Standard Deviation 18.69 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Day 10 (Change from Baseline) | -42.2 units on a scale | Standard Deviation 23.77 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 6 | 13.8 units on a scale | Standard Deviation 18.71 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 6 (Change from Baseline) | -44.5 units on a scale | Standard Deviation 19.9 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 12 | 15.2 units on a scale | Standard Deviation 17.79 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 12 (Change from Baseline) | -41.3 units on a scale | Standard Deviation 21.18 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 24 | 13.9 units on a scale | Standard Deviation 15.38 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 24 (Change from Baseline) | -44.2 units on a scale | Standard Deviation 18.64 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 36 | 7.9 units on a scale | Standard Deviation 13.53 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 52 (Change from Baseline) | -49.5 units on a scale | Standard Deviation 24.54 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 104/ET | 9.9 units on a scale | Standard Deviation 20.6 |
| Part II: Mechanical Debridement | Change in Visual Analog Scale (VAS) Scores From Baseline | Week 36 (Change from Baseline) | -49.6 units on a scale | Standard Deviation 17.18 |
Secondary
Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments
MRIs were obtained post-operatively at Day 10, obtained during the time period of Day 10 through Week 52, and again obtained during the time period of Week 52 through Week 104/ET). The images were evaluated using ICRS assessments of chondral lesions to determine the percentage of change in cartilage lesions over time post-operatively. ICRS partial-thickness chondral lesion assessment scores: Low-grade defect = less than 50% High-grade defect = 50% to 99%
Time frame: Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET
Population: Only Baseline subjects and subjects showing a percentage change in cartilage signal were included in the imaging results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part II: RF-based Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Weeks 52 to 104/ET - <50% Change in Lesion Fill | -5.2 units on a scale | Standard Deviation 13.4 |
| Part II: RF-based Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Day 10 to Week 52 - ≥50% Change in Lesion Fill | 1.2 units on a scale | Standard Deviation 11.1 |
| Part II: RF-based Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Postop Day 10 (Baseline) - Percent (%) Lesion Fill | 50.5 units on a scale | Standard Deviation 15.5 |
| Part II: RF-based Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Day 10 to Week 52 - <50% Change in Lesion Fill | -0.3 units on a scale | Standard Deviation 8.1 |
| Part II: RF-based Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Weeks 52 to 104/ET - ≥50% Change in Lesion Fill | 1.2 units on a scale | Standard Deviation 14.7 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Day 10 to Week 52 - ≥50% Change in Lesion Fill | -3.4 units on a scale | Standard Deviation 5.9 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Postop Day 10 (Baseline) - Percent (%) Lesion Fill | 52.9 units on a scale | Standard Deviation 16.6 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Day 10 to Week 52 - <50% Change in Lesion Fill | -1.9 units on a scale | Standard Deviation 4.4 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Weeks 52 to 104/ET - <50% Change in Lesion Fill | 2.9 units on a scale | Standard Deviation 8.8 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Weeks 52 to 104/ET - ≥50% Change in Lesion Fill | -3.4 units on a scale | Standard Deviation 8.6 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Weeks 52 to 104/ET - ≥50% Change in Lesion Fill | 3.7 units on a scale | Standard Deviation 4.7 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Weeks 52 to 104/ET - <50% Change in Lesion Fill | -6.0 units on a scale | Standard Deviation 11.9 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Postop Day 10 (Baseline) - Percent (%) Lesion Fill | 53.5 units on a scale | Standard Deviation 16.8 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Day 10 to Week 52 - ≥50% Change in Lesion Fill | -5.5 units on a scale | Standard Deviation 10.8 |
| Part II: Mechanical Debridement | Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments | Day 10 to Week 52 - <50% Change in Lesion Fill | 1.5 units on a scale | Standard Deviation 6.6 |
Secondary
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
Knee examination with respect to alignment (obvious varus, normal, obvious valgus) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the IKDC score questionnaires.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Alignment | Obvious Varus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Alignment | Normal | 19 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Baseline - Alignment | Obvious Varus | 1 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Baseline - Alignment | Normal | 26 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Baseline - Alignment | Obvious Valgus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Alignment | Obvious Varus | 1 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Alignment | Normal | 25 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Alignment | Obvious Valgus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Alignment | Obvious Varus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Alignment | Normal | 25 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Alignment | Obvious Valgus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Alignment | Obvious Varus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Alignment | Normal | 24 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Alignment | Obvious Valgus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Alignment | Obvious Valgus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Alignment | Obvious Varus | 1 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Alignment | Normal | 19 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Alignment | Obvious Valgus | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Alignment | Obvious Varus | 1 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Alignment | Normal | 19 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Alignment | Obvious Valgus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Alignment | Obvious Valgus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Alignment | Obvious Varus | 1 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Alignment | Obvious Varus | 1 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Alignment | Normal | 21 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Alignment | Obvious Varus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Baseline - Alignment | Obvious Varus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Alignment | Normal | 20 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Baseline - Alignment | Normal | 29 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Alignment | Normal | 23 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Baseline - Alignment | Obvious Valgus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Alignment | Obvious Valgus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Alignment | Obvious Varus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Alignment | Obvious Valgus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Alignment | Normal | 26 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Alignment | Obvious Valgus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Alignment | Obvious Valgus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Alignment | Obvious Valgus | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Alignment | Obvious Varus | 1 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Alignment | Normal | 14 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Alignment | Normal | 25 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Alignment | Obvious Varus | 0 Participants |
Secondary
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
Knee examination with respect to generalized laxity (tight, normal, lax) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the IKDC score questionnaires.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Baseline - Generalized Laxity | Tight | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Baseline - Generalized Laxity | Normal | 28 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Baseline - Generalized Laxity | Lax | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Generalized Laxity | Tight | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Generalized Laxity | Normal | 26 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Generalized Laxity | Lax | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Generalized Laxity | Tight | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Generalized Laxity | Normal | 25 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Generalized Laxity | Lax | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Generalized Laxity | Tight | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Generalized Laxity | Normal | 24 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Generalized Laxity | Lax | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Generalized Laxity | Tight | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Generalized Laxity | Normal | 19 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Generalized Laxity | Lax | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Generalized Laxity | Tight | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Generalized Laxity | Normal | 20 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Generalized Laxity | Lax | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Generalized Laxity | Tight | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Generalized Laxity | Normal | 20 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Generalized Laxity | Lax | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Generalized Laxity | Normal | 23 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Baseline - Generalized Laxity | Tight | 1 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Generalized Laxity | Tight | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Baseline - Generalized Laxity | Normal | 28 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Generalized Laxity | Lax | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Baseline - Generalized Laxity | Lax | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Generalized Laxity | Normal | 20 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Generalized Laxity | Tight | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Generalized Laxity | Tight | 1 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Generalized Laxity | Normal | 26 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Generalized Laxity | Lax | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 6 - Generalized Laxity | Lax | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Generalized Laxity | Normal | 21 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Generalized Laxity | Tight | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Generalized Laxity | Lax | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Generalized Laxity | Normal | 26 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 36 - Generalized Laxity | Lax | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 12 - Generalized Laxity | Lax | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 104/ET - Generalized Laxity | Normal | 15 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 24 - Generalized Laxity | Tight | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation | IKDC Score at Week 52 - Generalized Laxity | Tight | 0 Participants |
Secondary
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
Knee examination with respect to patella position (obvious baja, normal, obvious alta) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the IKDC score questionnaires.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Patella Position | Obvious Baja | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Patella Position | Normal | 28 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Patella Position | Obvious Alta | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Patella Position | Obvious Baja | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Patella Position | Normal | 26 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Patella Position | Obvious Alta | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Patella Position | Obvious Baja | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Patella Position | Normal | 25 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Patella Position | Obvious Alta | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Patella Position | Obvious Baja | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Patella Position | Normal | 24 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Patella Position | Obvious Alta | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Patella Position | Obvious Baja | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Patella Position | Normal | 19 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Patella Position | Obvious Alta | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Patella Position | Obvious Baja | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Patella Position | Normal | 20 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Patella Position | Obvious Alta | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Patella Position | Obvious Baja | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Patella Position | Normal | 20 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Patella Position | Obvious Alta | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Patella Position | Normal | 23 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Patella Position | Obvious Baja | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Patella Position | Obvious Baja | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Patella Position | Normal | 29 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Patella Position | Obvious Alta | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Patella Position | Obvious Alta | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Patella Position | Normal | 20 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Patella Position | Obvious Baja | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Patella Position | Obvious Baja | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Patella Position | Normal | 26 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Patella Position | Obvious Alta | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Patella Position | Obvious Alta | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Patella Position | Normal | 22 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Patella Position | Obvious Baja | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Patella Position | Obvious Alta | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Patella Position | Normal | 26 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Patella Position | Obvious Alta | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Patella Position | Obvious Alta | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Patella Position | Normal | 15 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Patella Position | Obvious Baja | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Patella Position | Obvious Baja | 0 Participants |
Secondary
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
Knee examination with respect to patella subluxation/ dislocation (centered, subluxable, subluxed and dislocated) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits. The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury. There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows: IKDC score = (raw score - lowest possible score / range of scores) x100
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Population: Not all participants completed the IKDC score questionnaires.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Subluxation/Dislocation | Centered | 19 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Subluxation/Dislocation | Centered | 25 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Subluxation/Dislocation | Centered | 20 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Subluxation/Dislocation | Centered | 26 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Sublux/Dislocation | Centered | 20 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Sublux/Dislocation | Subluxable | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Subluxation/Dislocation | Centered | 24 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Sublux/Dislocation | Subluxed | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Subluxation/Dislocation | Centered | 28 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Sublux/Dislocation | Dislocated | 0 Participants |
| Part II: RF-based Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Sublux/Dislocation | Dislocated | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Subluxation/Dislocation | Centered | 29 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Baseline - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Subluxation/Dislocation | Centered | 25 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Subluxation/Dislocation | Subluxable | 1 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 6 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Subluxation/Dislocation | Centered | 26 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Subluxation/Dislocation | Centered | 23 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 24 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Subluxation/Dislocation | Centered | 21 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 36 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Subluxation/Dislocation | Centered | 20 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Subluxation/Dislocation | Subluxable | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Subluxation/Dislocation | Subluxed | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 52 - Subluxation/Dislocation | Dislocated | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Sublux/Dislocation | Centered | 15 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Sublux/Dislocation | Subluxable | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 104/ET - Sublux/Dislocation | Subluxed | 0 Participants |
| Part II: Mechanical Debridement | Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation | IKDC Scores at Week 12 - Subluxation/Dislocation | Subluxed | 0 Participants |
Secondary
Subject Satisfaction Postoperatively at Weeks 52 and 104
Subjects were questioned regarding their satisfaction with study treatment for knee pain.
Time frame: Postop Weeks 52 and 104/ET
Population: Not all participants completed the subject satisfaction questionnaire.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Very Satisfied | 12 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Somewhat Dissatisfied | 2 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Very Satisfied | 15 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Extremely Satisfied | 0 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Somewhat Satisfied | 5 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Very Dissatisfied | 0 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Somewhat Dissatisfied | 0 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Somewhat Satisfied | 5 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Very Dissatisfied | 0 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Extremely Dissatisfied | 0 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Extremely Dissatisfied | 0 Participants |
| Part II: RF-based Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Extremely Satisfied | 0 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Extremely Dissatisfied | 0 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Extremely Satisfied | 0 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Very Satisfied | 16 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Somewhat Satisfied | 2 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Somewhat Dissatisfied | 2 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Very Dissatisfied | 0 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 52 | Extremely Dissatisfied | 0 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Extremely Satisfied | 0 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Very Satisfied | 13 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Somewhat Satisfied | 2 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Somewhat Dissatisfied | 0 Participants |
| Part II: Mechanical Debridement | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Week 104/ET | Very Dissatisfied | 0 Participants |