Avascular Necrosis of the Femoral Condyle, Chronic Osteoarthritis, Knee Pain, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
Conditions
Brief summary
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.
Detailed description
The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
Interventions
DEVICEPERSONA Total Knee
Primary Total Knee Arthroplasty
DEVICEVanguard Total Knee
Primary Total Knee Arthroplasty
DEVICENexGen Total Knee
Primary Total Knee Arthroplasty
Sponsors
Zimmer Biomet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient is a minimum of 18 years of age * Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard knee components implanted in accordance with product labeling * Patient has participated in this study-related Informed Consent process * Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form * Patient is willing and able to complete scheduled study procedures and follow-up evaluations
Exclusion criteria
* Patient is currently participating in any other surgical intervention studies or pain management studies * Patient has underwent contralateral UKA or TKA within the last 18 months * Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum) * Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation) * Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) * Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance | Pre-op (Baseline), 6 weeks, 3 months, and 1 year | EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score. |
| Oxford | Pre-op (Baseline), 6 weeks, 3 months, and 1 year | Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe). |
| Post-Operative Pain & Satisfaction | 6 weeks, 3 months, and 1 year | Post-Operative Pain & Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied. |
| Total Range of Motion | Pre-op (Baseline), 6 weeks, 3 months, and 1 year | Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop |
Countries
United States
Participant flow
Recruitment details
A maximum of 300 subjects are to be competitively enrolled in this study across all sites; a maximum of 10 U.S sites will contribute, with participating sites each enrolling up to 75 implanted knees. Sites will enroll up to 45 patients using The ROSA Knee System and up to 30 patients using Conventional instrumentation using a consecutive and concurrent approach; total study enrollment into these arms is not to exceed 180 subjects and 120 subjects respectively.
Participants by arm
| Arm | Count |
|---|---|
| Robotic Assisted TKA Robotic Assisted TKA
PERSONA Total Knee: Primary Total Knee Arthroplasty
Vanguard Total Knee: Primary Total Knee Arthroplasty
NexGen Total Knee: Primary Total Knee Arthroplasty | 133 |
| Robotic Assisted TKA Robotic Assisted TKA
PERSONA Total Knee: Primary Total Knee Arthroplasty
Vanguard Total Knee: Primary Total Knee Arthroplasty
NexGen Total Knee: Primary Total Knee Arthroplasty | 133 |
| Conventional TKA Conventional TKA
PERSONA Total Knee: Primary Total Knee Arthroplasty
Vanguard Total Knee: Primary Total Knee Arthroplasty
NexGen Total Knee: Primary Total Knee Arthroplasty | 48 |
| Conventional TKA Conventional TKA
PERSONA Total Knee: Primary Total Knee Arthroplasty
Vanguard Total Knee: Primary Total Knee Arthroplasty
NexGen Total Knee: Primary Total Knee Arthroplasty | 48 |
| Total | 362 |
Baseline characteristics
| Characteristic | Robotic Assisted TKA | Conventional TKA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Knees | 0 Knees | 0 Knees |
| Age, Categorical >=65 years | 92 Knees | 33 Knees | 125 Knees |
| Age, Categorical Between 18 and 65 years | 41 Knees | 15 Knees | 56 Knees |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Knees | 1 Knees | 2 Knees |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Knees | 47 Knees | 179 Knees |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Knees | 0 Knees | 0 Knees |
| Kellgren Lawrence KL Grade ≥ 3 No | 29 Knees | 10 Knees | 39 Knees |
| Kellgren Lawrence KL Grade ≥ 3 Yes | 99 Knees | 36 Knees | 135 Knees |
| Sex: Female, Male Female | 74 Knees | 28 Knees | 102 Knees |
| Sex: Female, Male Male | 59 Knees | 20 Knees | 79 Knees |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 133 | 0 / 48 |
| other Total, other adverse events | 52 / 133 | 20 / 48 |
| serious Total, serious adverse events | 7 / 133 | 1 / 48 |
Outcome results
Primary
Clinical Performance
EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Population: Only subjects with valid EQ5D scores at the follow-up time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted TKA | Clinical Performance | Preop | .540 score on a scale | Standard Deviation 0.268 |
| Robotic Assisted TKA | Clinical Performance | 6 Week | .740 score on a scale | Standard Deviation 0.166 |
| Robotic Assisted TKA | Clinical Performance | 3 Month | .826 score on a scale | Standard Deviation 0.137 |
| Robotic Assisted TKA | Clinical Performance | 1 Year | .889 score on a scale | Standard Deviation 0.145 |
| Conventional TKA | Clinical Performance | 1 Year | .891 score on a scale | Standard Deviation 0.137 |
| Conventional TKA | Clinical Performance | Preop | .442 score on a scale | Standard Deviation 0.256 |
| Conventional TKA | Clinical Performance | 3 Month | .842 score on a scale | Standard Deviation 0.128 |
| Conventional TKA | Clinical Performance | 6 Week | .763 score on a scale | Standard Deviation 0.179 |
Primary
Oxford
Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Population: Only subjects with valid Oxford scores at the follow-up time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted TKA | Oxford | Preop | 24.6 score on a scale | Standard Deviation 9.2 |
| Robotic Assisted TKA | Oxford | 6 Week | 32.0 score on a scale | Standard Deviation 7.6 |
| Robotic Assisted TKA | Oxford | 3 Month | 38.2 score on a scale | Standard Deviation 6.8 |
| Robotic Assisted TKA | Oxford | 1 Year | 42.4 score on a scale | Standard Deviation 5.4 |
| Conventional TKA | Oxford | 1 Year | 41.2 score on a scale | Standard Deviation 5.8 |
| Conventional TKA | Oxford | Preop | 22.2 score on a scale | Standard Deviation 8.2 |
| Conventional TKA | Oxford | 3 Month | 38.5 score on a scale | Standard Deviation 6.9 |
| Conventional TKA | Oxford | 6 Week | 32.5 score on a scale | Standard Deviation 6.8 |
Primary
Post-Operative Pain & Satisfaction
Post-Operative Pain & Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.
Time frame: 6 weeks, 3 months, and 1 year
Population: Only subjects with Patient Satisfaction form at the follow-up time points are included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 6 Week | Very Satisfied | 80 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 6 Week | Satisfied | 32 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 6 Week | Uncertain | 12 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 6 Week | Unsatisfied | 0 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 3 Month | Very Satisfied | 89 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 3 Month | Satisfied | 22 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 3 Month | Uncertain | 9 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 3 Month | Unsatisfied | 0 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 1 Year | Very Satisfied | 77 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 1 Year | Satisfied | 11 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 1 Year | Uncertain | 6 Knee |
| Robotic Assisted TKA | Post-Operative Pain & Satisfaction | 1 Year | Unsatisfied | 1 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 1 Year | Uncertain | 3 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 6 Week | Very Satisfied | 32 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 3 Month | Uncertain | 1 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 6 Week | Satisfied | 9 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 1 Year | Satisfied | 8 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 6 Week | Uncertain | 2 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 3 Month | Unsatisfied | 0 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 6 Week | Unsatisfied | 1 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 1 Year | Unsatisfied | 0 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 3 Month | Very Satisfied | 34 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 1 Year | Very Satisfied | 23 Knee |
| Conventional TKA | Post-Operative Pain & Satisfaction | 3 Month | Satisfied | 7 Knee |
Primary
Total Range of Motion
Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop
Time frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Population: Only subjects with valid ROM scores at the follow-up time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted TKA | Total Range of Motion | Preop | 121.0 degrees | Standard Deviation 13.9 |
| Robotic Assisted TKA | Total Range of Motion | 6 Week | 114.5 degrees | Standard Deviation 12.9 |
| Robotic Assisted TKA | Total Range of Motion | 3 Month | 121.1 degrees | Standard Deviation 11 |
| Robotic Assisted TKA | Total Range of Motion | 1 Year | 122.7 degrees | Standard Deviation 9.5 |
| Conventional TKA | Total Range of Motion | 1 Year | 120.4 degrees | Standard Deviation 10.8 |
| Conventional TKA | Total Range of Motion | Preop | 115.7 degrees | Standard Deviation 16.2 |
| Conventional TKA | Total Range of Motion | 3 Month | 120.7 degrees | Standard Deviation 9.7 |
| Conventional TKA | Total Range of Motion | 6 Week | 111.4 degrees | Standard Deviation 11.1 |