Osteoarthritis of the Knee
Conditions
Keywords
randomized clinical trial, osteoarthritis, radiofrequency ablation, knee, genicular, cross-over, viscosupplementation
Brief summary
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group after completing the 6-month endpoint assessment. They will be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success. Subjects who were randomized to and received COOLIEF\* as their initial treatment will have the option to add 2 additional visits at 6-month intervals, representing 18 and 24 months post initial treatment.
Detailed description
The COOLIEF™ system components utilized in the study are the same in form and function regardless of specific product branding (COOLIEF\* or SInergy\*). The COOLIEF™ system is comprised of three primary components (collectively known as 'disposables') and is used in conjunction with the Pain Management generator, pump unit, connector cables (collectively known as 'Hardware') and dispersive electrodes (also known as 'grounding pads'): * Cooled Radiofrequency Sterile Tube Kit (sterile, single use, non-body contact): It is used for closed-loop circulation of sterile water through a Halyard Health\* Cooled Radiofrequency Probe. It includes a burette and tubing. * Cooled Radiofrequency Introducer (sterile, single use): It is to be used with the Probes only. The Cooled Radiofrequency Introducer provides a path for the Probe to the targeted nervous tissue. * Cooled Radiofrequency Probe (sterile, single use): It is inserted through an Introducer into or near nervous tissue. The active tip extends 4mm from the introducer and delivers energy. Sterile water circulates internally to cool the Probe while it delivers radiofrequency energy. A thermocouple in the Probe measures the cooled electrode temperature throughout the procedure. The product is comprised of an electrically insulated shaft with an active tip that functions as an electrode for radiofrequency energy delivery, a handle, tubes with luer locks and a cable with a 7-pin connector. The Introducer includes an insulated stainless steel cannula and a stylet. The Tube Kit is comprised of a burette and flexible tubing fitted with luer locks for connection to the Probe. The Probe, Introducer, and Tube Kit are ethylene oxide sterilized and supplied sterile. These components can be packaged together in a kit or as separate components. The devices should be stored in a cool, dry environment. The Instructions For Use (IFU) documents (Appendix 1) are included in each kit. Halyard Health maintains a list of all model numbers and sizes for the system components. The control product/device, Synvisc-One® (hylan G-F 20) (HA), is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium hyaluronate). Hylan G-F 20 is unique in that the hyaluronan is chemically crosslinked. Hyaluronan is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine. Synvisc-One is a single injection regimen therapy indicated for the treatment of pain in Osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen. Following treatment, subjects in the CRF treatment group will follow up at 1, 3, 6 and 12 months. These subjects will then have the option to return for two additional visits at 18 and 24 months. Subjects initially randomized to the comparison (HA) group will follow up at 1, 3, and 6 months, and then be given the option to receive crossover CRF treatment. If crossover CRF treatment was received, subjects will return for follow up visits at 1, 3, and 6 months post-treatment. If crossover treatment was not received, subjects will return for their final 12 month visit. Study Duration: * Treatment Group: Up to 24 months following index procedure * Control Group: Up to 13 months, depending upon receipt of cross-over procedure. Effectiveness Endpoints: * Numeric Rating Scale (NRS, Usual Level of Pain) * Western Ontario & McMaster University Osteoarthritis Index (WOMAC) * EQ-5D-5L Health-Related Quality of Life Questionnaire * Global Perceived Effect Scale
Interventions
DEVICECooled Radiofrequency
Delivery of energy to ablate sensory nerves via cooled radiofrequency probe.
Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain.
OTHERCrossover from Hyaluronic Acid Injection to Cooled Radiofrequency
Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain. After 6 months, qualifying subjects in this group will have the option to crossover to receive cooled radiofrequency treatment.
Sponsors
Avanos Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 21 years 2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures 3. Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.) 4. Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs \[NSAIDs\]) 5. Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee 6. Pain on NRS ≥ 6 on an 11-point scale for the index knee 7. Radiologic confirmation of arthritis (x-ray/MRI/CT) of Osteoarthritis (OA) grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee 8. An intra-articular hyaluronic acid injection is indicated as an appropriate treatment option 9. WOMAC Knee Score group at baseline of Score of ≥ 2 (0 to 4 scale) on WOMAC question 1 (Pain) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale. 10. Analgesics including membrane stabilizers such as Neurontin/gabapentin and antidepressants for pain such as Cymbalta/duloxetine must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the course of the study without approval of the investigator 11. Agree to see one physician (study physician) for knee pain during the study period 12. Willing to utilize double barrier contraceptive method if of child bearing potential. 13. Willing to delay any surgical intervention for the index knee for the period of the study follow up 14. Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study
Exclusion criteria
1. Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain 2. Evidence of neuropathic pain affecting the index knee 3. Previous or pending lower limb amputation 4. Intra-articular steroid injection into the index knee within 90 days from randomization 5. Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization 6. Prior radiofrequency ablation of the genicular nerves of the index knee 7. Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware) 8. Clinically significant ligamentous laxity of the index knee 9. Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations 10. Body mass index (BMI) \> 40 kg/m2 11. Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns 12. Pending or active compensation claim, litigation or disability remuneration (secondary gain) 13. Pregnant, nursing or intent on becoming pregnant during the study period 14. Chronic pain associated with significant psychosocial dysfunction 15. Beck's Depression Index score of \> 22 (indicates clinically depressed state) 16. Allergies to any of the medications to be used during the procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry) 17. Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved) 18. History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable. 19. Identifiable anatomical variability that would materially alter the procedure as described in the protocol 20. Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse 21. Current prescribed opioid medications greater than 60 morphine equivalent daily opioid dose 22. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.) 23. Subject currently implanted with pacemaker, stimulator or defibrillator. 24. Participating in another clinical trial/investigation within 30 days prior to signing informed consent 25. Subject unwilling or unable to comply with follow up schedule or protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | Baseline to 6 month study visit | The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain. There are no sub-scales. |
| Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up. | Baseline to 12 month study visit | Safety: The proportion of subjects experiencing adverse events through final follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale | Baseline (or date of crossover for Crossover group subjects) to 12 month study visit | The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain. There are no sub-scales. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline to 6 month study visit | The change in WOMAC score from baseline to 6 months. This outcome instrument is composed of three sub-scales, including Pain (5 questions), Stiffness (2 questions), and Physical Function (17 questions). The point range for each sub-scale question is from 0 to 4, with 0 indicating the best study subject condition and 4 indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for Pain, Stiffness, and Physical Function, respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition). |
Other
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L | Baseline to 6 month study visit | The change in measured EQ-5D-5L scale from baseline to 6 months. This outcome instrument is composed of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with 1 indicating the best study subject condition and 5 indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. |
| Safety: The Proportion of Subjects Experiencing Adverse Events Between 12 - 24 Months (Extension) | 12 month study visit to 24 month study visit | Safety: The proportion of subjects experiencing adverse events between 12 - 24 months (Extension) |
| Global Perceived Effect | Baseline to 6 month study visit | Number of participants with improvement measured by the Global Perceived Effect scale. The Global Perceived Effect is a 7-point scale: 1 point = worst ever, 2 points = much worse, 3 points = worse, 4 points = not improved but not worse, 5 points = improved, 6 points = much improved, 7 points = best ever. There are no sub-scales. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported. |
| Numeric Rating Scale | Baseline to 18 month study visit | The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain. There are no sub-scales. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline to 18 month study visit | The change in WOMAC score from baseline to 18 months. This outcome instrument is composed of three sub-scales, including Pain (5 questions), Stiffness (2 questions), and Physical Function (17 questions). The point range for each sub-scale question is from 0 to 4, with 0 indicating the best study subject condition and 4 indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for Pain, Stiffness, and Physical Function, respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cooled Radiofrequency Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain
Cooled Radiofrequency: Delivery of energy to ablate sensory nerves via cooled radiofrequency probe | 89 |
| Hyaluronic Acid Injection Hyaluronic acid injections will be administered to study subjects' knees to reduce knee pain
Hyaluronic Acid: Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain | 88 |
| Total | 177 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 0-6 Months | Adverse Event | 1 | 0 |
| 0-6 Months | Lack of Efficacy | 1 | 0 |
| 0-6 Months | Lost to Follow-up | 3 | 2 |
| 0-6 Months | Physician Decision | 1 | 0 |
| 0-6 Months | Planning another procedure | 1 | 2 |
| 0-6 Months | Protocol Violation | 2 | 1 |
| 0-6 Months | Withdrawal by Subject | 4 | 1 |
| 12 - 24 Months (Extension Study) | Lost to Follow-up | 1 | 0 |
| 12 - 24 Months (Extension Study) | Received another procedure | 5 | 0 |
| 12 - 24 Months (Extension Study) | Withdrawal by Subject | 3 | 0 |
| 6-12 Months | Lost to Follow-up | 0 | 2 |
| 6-12 Months | Planning another procedure | 6 | 2 |
| 6-12 Months | Protocol Violation | 3 | 2 |
| 6-12 Months | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Cooled Radiofrequency | Total | Hyaluronic Acid Injection |
|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 10.7 | 63.2 years STANDARD_DEVIATION 10.2 | 63.1 years STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 11 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 83 Participants | 163 Participants | 80 Participants |
| Region of Enrollment United States | 89 participants | 177 participants | 88 participants |
| Sex: Female, Male Female | 52 Participants | 106 Participants | 54 Participants |
| Sex: Female, Male Male | 37 Participants | 71 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 88 | 0 / 68 |
| other Total, other adverse events | 85 / 89 | 46 / 88 | 37 / 68 |
| serious Total, serious adverse events | 13 / 89 | 2 / 88 | 1 / 68 |
Outcome results
Primary
Numeric Rating Scale (NRS)
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain. There are no sub-scales.
Time frame: Baseline to 6 month study visit
Population: 76 of the 89 originally-randomized study subjects in the Cooled Radiofrequency group completed this 6-month outcome. 82 of the originally-randomized 88 study subjects in the Hyaluronic Acid Injection group completed this 6-month outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Numeric Rating Scale (NRS) | 54 Participants |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | Numeric Rating Scale (NRS) | 31 Participants |
Primary
Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up.
Safety: The proportion of subjects experiencing adverse events through final follow up.
Time frame: Baseline to 12 month study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up. | 78 Participants |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up. | 48 Participants |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | Safety: The Proportion of Subjects Experiencing Adverse Events Through Final Follow up. | 38 Participants |
Secondary
Numeric Rating Scale
The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain. There are no sub-scales.
Time frame: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit
Population: 66 of the 89 originally-randomized study subjects in the Cooled Radiofrequency group completed this 12-month outcome measure. 62 of the originally-randomized 88 study subjects in the Hyaluronic Acid Injection group chose to crossover to receive Cooled Radiofrequency treatment and completed this 12-month outcome. 11 of the originally-randomized subjects in this group who elected not to crossover completed this 12-month outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Numeric Rating Scale | 43 Participants |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | Numeric Rating Scale | 10 Participants |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | Numeric Rating Scale | 40 Participants |
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The change in WOMAC score from baseline to 6 months. This outcome instrument is composed of three sub-scales, including Pain (5 questions), Stiffness (2 questions), and Physical Function (17 questions). The point range for each sub-scale question is from 0 to 4, with 0 indicating the best study subject condition and 4 indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for Pain, Stiffness, and Physical Function, respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).
Time frame: Baseline to 6 month study visit
Population: The 'change from baseline' was unable to be calculated for one of the CRFA-randomized subjects as appropriate baseline measurements for this outcome measure were not collected. The comparison could not be performed for this subject. Therefore, the Overall Number of Participants Analyzed in this group is reduced by one.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Radiofrequency | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 31.5 units on a scale | Standard Deviation 23 |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 14.8 units on a scale | Standard Deviation 19.4 |
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The change in WOMAC score from baseline to 12 months. This outcome instrument is composed of three sub-scales, including Pain (5 questions), Stiffness (2 questions), and Physical Function (17 questions). The point range for each sub-scale question is from 0 to 4, with 0 indicating the best study subject condition and 4 indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for Pain, Stiffness, and Physical Function, respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).
Time frame: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit
Population: The 'change from baseline' was unable to be calculated for one of the CRFA-randomized subjects as appropriate baseline measurements for this outcome measure were not collected. The comparison could not be performed for this subject. Therefore, the Overall Number of Participants Analyzed in this group is reduced by one.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Radiofrequency | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 30.7 units on a scale | Standard Deviation 25.2 |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 32.1 units on a scale | Standard Deviation 18.3 |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 18.1 units on a scale | Standard Deviation 22.1 |
Other Pre-specified
EQ-5D-5L
The change in measured EQ-5D-5L scale from baseline to 18 months. This outcome instrument is composed of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with 1 indicating the best study subject condition and 5 indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Time frame: Baseline to 18 month study visit
Population: Extension study subjects with 18-month data available for analysis for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Radiofrequency | EQ-5D-5L | 0.15 units on a scale | Standard Deviation 0.14 |
Other Pre-specified
EQ-5D-5L
The change in measured EQ-5D-5L scale from baseline to 24 months. This outcome instrument is composed of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with 1 indicating the best study subject condition and 5 indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Time frame: Baseline to 24 month study visit
Population: Extension study subjects with 18-month data available for analysis for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Radiofrequency | EQ-5D-5L | 0.07 units on a scale | Standard Deviation 0.14 |
Other Pre-specified
EQ-5D-5L
The change in measured EQ-5D-5L scale from baseline to 6 months. This outcome instrument is composed of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with 1 indicating the best study subject condition and 5 indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Time frame: Baseline to 6 month study visit
Population: The 'change from baseline' was unable to be calculated for one of the CRFA-randomized subjects as appropriate baseline measurements for this outcome measure were not collected. The comparison could not be performed for this subject. Therefore, the Overall Number of Participants Analyzed in this group is reduced by one.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Radiofrequency | EQ-5D-5L | 0.12 units on a scale | Standard Deviation 0.14 |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | EQ-5D-5L | 0.06 units on a scale | Standard Deviation 0.15 |
Other Pre-specified
EQ-5D-5L
The change in measured EQ-5D-5L scale from baseline to 12 months. This outcome instrument is composed of five sub-scales containing five questions each. The point range for each sub-scale is from 1 to 5, with 1 indicating the best study subject condition and 5 indicating the worst study subject condition. Thus, the minimum and maximum scores per sub-scale are 1 and 5, respectively, and such scores for the entire instrument are 5 (best study subject condition) and 25 (worst study subject condition). The sub-scale topics are: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Time frame: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit
Population: The 'change from baseline' was unable to be calculated for one of the CRFA-randomized subjects as appropriate baseline measurements for this outcome measure were not collected. The comparison could not be performed for this subject. Therefore, the Overall Number of Participants Analyzed in this group is reduced by one.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Radiofrequency | EQ-5D-5L | 0.12 units on a scale | Standard Deviation 0.14 |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | EQ-5D-5L | 0.14 units on a scale | Standard Deviation 0.14 |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | EQ-5D-5L | 0.08 units on a scale | Standard Deviation 0.15 |
Other Pre-specified
Global Perceived Effect
Number of participants with improvement measured by the Global Perceived Effect scale. The Global Perceived Effect is a 7-point scale: 1 point = worst ever, 2 points = much worse, 3 points = worse, 4 points = not improved but not worse, 5 points = improved, 6 points = much improved, 7 points = best ever. There are no sub-scales. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported.
Time frame: Baseline (or date of crossover for Crossover group subjects) to 12 month study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Global Perceived Effect | 42 Participants |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | Global Perceived Effect | 8 Participants |
| Crossover From Hyaluronic Acid Injection to Cooled Radiofrequency | Global Perceived Effect | 39 Participants |
Other Pre-specified
Global Perceived Effect
Number of participants with improvement measured by the Global Perceived Effect scale. The Global Perceived Effect is a 7-point scale: 1 point = worst ever, 2 points = much worse, 3 points = worse, 4 points = not improved but not worse, 5 points = improved, 6 points = much improved, 7 points = best ever. There are no sub-scales. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported.
Time frame: Baseline to 6 month study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Global Perceived Effect | 55 Participants |
| Hyaluronic Acid Injection, Then Cooled Radiofrequency Crossover Option | Global Perceived Effect | 33 Participants |
Other Pre-specified
Global Perceived Effect
Number of participants with improvement measured by the Global Perceived Effect scale. The Global Perceived Effect is a 7-point scale: 1 point = worst ever, 2 points = much worse, 3 points = worse, 4 points = not improved but not worse, 5 points = improved, 6 points = much improved, 7 points = best ever. There are no sub-scales. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported.
Time frame: Baseline to 24 month study visit
Population: Extension study subjects with 18-month data available for analysis for this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Global Perceived Effect | 17 Participants |
Other Pre-specified
Global Perceived Effect
Number of participants with improvement measured by the Global Perceived Effect scale. The Global Perceived Effect is a 7-point scale: 1 point = worst ever, 2 points = much worse, 3 points = worse, 4 points = not improved but not worse, 5 points = improved, 6 points = much improved, 7 points = best ever. There are no sub-scales. Number of participants scoring at either 5, 6, or 7 points on the Global Perceived Effect scale are reported.
Time frame: Baseline to 18 month study visit
Population: Extension study subjects with 18-month data available for analysis for this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Global Perceived Effect | 24 Participants |
Other Pre-specified
Numeric Rating Scale
The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain. There are no sub-scales.
Time frame: Baseline to 18 month study visit
Population: 32 of the 36 study subjects who elected to participate in the CRFA extension phase of the study completed this 18-month outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Numeric Rating Scale | 22 Participants |
Other Pre-specified
Numeric Rating Scale
The proportion of subjects whose knee pain is reduced from baseline by ≥ 50% based on the NRS. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain. There are no sub-scales.
Time frame: Baseline to 24 month study visit
Population: 27 of the 36 study subjects who elected to participate in the CRFA extension phase of the study completed this 24-month outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Numeric Rating Scale | 17 Participants |
Other Pre-specified
Safety: The Proportion of Subjects Experiencing Adverse Events Between 12 - 24 Months (Extension)
Safety: The proportion of subjects experiencing adverse events between 12 - 24 months (Extension)
Time frame: 12 month study visit to 24 month study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cooled Radiofrequency | Safety: The Proportion of Subjects Experiencing Adverse Events Between 12 - 24 Months (Extension) | 19 Participants |
Other Pre-specified
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The change in WOMAC score from baseline to 24 months. This outcome instrument is composed of three sub-scales, including Pain (5 questions), Stiffness (2 questions), and Physical Function (17 questions). The point range for each sub-scale question is from 0 to 4, with 0 indicating the best study subject condition and 4 indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for Pain, Stiffness, and Physical Function, respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).
Time frame: Baseline to 24 month study visit
Population: Extension study subjects with 24-month data available for analysis for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Radiofrequency | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 41.3 units on a scale | Standard Deviation 29.9 |
Other Pre-specified
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The change in WOMAC score from baseline to 18 months. This outcome instrument is composed of three sub-scales, including Pain (5 questions), Stiffness (2 questions), and Physical Function (17 questions). The point range for each sub-scale question is from 0 to 4, with 0 indicating the best study subject condition and 4 indicating the worst study subject condition. Thus, the minimum score per sub-scale is 0, and the maximum is 20, 8, and 68 for Pain, Stiffness, and Physical Function, respectively. The minimum and maximum possible scores for the entire instrument are 0 (best study subject condition) and 96 (worst study subject condition).
Time frame: Baseline to 18 month study visit
Population: Extension study subjects with 18-month data available for analysis for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cooled Radiofrequency | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 29.3 units on a scale | Standard Deviation 25.3 |