Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.

Detailed Description
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RCT of 100 subjects undergoing primary TKA who were randomized to received either a SCORPIO™ PCS or PCR TKA. Subjects were evaluated pre-operatively and at 2 and 10 years post-operatively using the Western Ontario (WOMAC) Osteoarthritis Index, the RAND-36 and knee range of motion (2 years only). Complication and revision rates were also evaluated.

Official Title
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SCORPIO™ Posterior Stabilized Versus Posterior Retained Total Knee Arthroplasties: Long-term Functional and Radiographic Outcome

Conditions
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Arthroplasty, Replacement, Knee, Knee Arthroplasty, Total

Intervention / Treatment
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* Device: SCORPIO™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for primary TKA non-inflammatory arthritis intact Posterior Cruciate Ligament at the time of surgery Exclusion Criteria: required bone grafting of either the femur or tibia varus or valgus deformity of > 15 degrees previous high tibial osteotomy unable to understand or comply with the study requirements unable to provide signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCS<br>SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis | Device: SCORPIO™<br>* subjects randomized at surgery to receive 1 of the 2 specified implants<br>|
| Active Comparator: PCR<br>SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis | Device: SCORPIO™<br>* subjects randomized at surgery to receive 1 of the 2 specified implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain | disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores | 10 years postoperative | 
| WOMAC Osteoarthritis Index Function | disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAND -36 Health Survey | generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function. | 10 years postoperative | 
| Revision Rate | number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases | within 10 years of surgery | 
| Number of Complications |  | within 10 years of surgery | 
| Knee Range of Motion | Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees | knee ROM at 2 years postoperative |