Study of Knee Replacements for Patellofemoral Osteoarthritis

Study Overview
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Brief Summary
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This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.

Detailed Description
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Isolated patellofemoral osteoarthritis can be a disabling condition of the knee necessitating knee arthroplasty. It is debated whether total knee replacement or isolated patellofemoral replacement is the better treatment option. This randomized trial attempts to give a qualified answer to the debate by comparing clinical outcome (range of movement, stability, effusion, patellofemoral tracking, tenderness, stair climbing), patient self assessment scores (EQ-5D, Oxford Knee Score, KOOS, SF-36, AKS), complications (infections, revisions), longevity (survival analysis) and cost (direct and indirect) for the two implant types. The Avon patellofemoral implant has been chosen, as this is the patellofemoral implant with the best documentation. The PFC Sigma CR total knee implant has been chosen as it a current standard implant and market leader.

Official Title
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Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated PF-OA Exclusion Criteria: Medial or lateral OA

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avon patellofemoral replacement<br>Knee arthroplasty with insertion of patellofemoral joint replacement. | Device: Knee arthroplasty<br>* Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.<br>* Other names: TKR: PFC Sigma CR arthroplasty (DePuy);|
| Active Comparator: PFC Sigma CR total knee replacement<br>Knee arthroplasty with total (tricompartmental) knee replacement. | Device: Knee arthroplasty<br>* Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.<br>* Other names: TKR: PFC Sigma CR arthroplasty (DePuy);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcomes (disease-specific and generic QoL instruments) | The physical functioning score of the Short Form (36) Health Survey is the primary outcome measure of the study. Disease-specific patient-reported outcomes (Oxford Knee Score, KOOS and Kujala) and a second generic quality of life measure (EQ5D). | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival, clinician assessment and cost. | Secondary outcome measures relate to implant survival, clinician assessment and cost. Implant survival will be assessed by 5- and 10-year implant survival rates and by analyzing causes for revision surgery. Clinician assessment includes Knee Society Score (stability, range of movement, effusion, tenderness etc.). Assessments of immediate and long-term costs are based on patient diaries, sick leave, use of medical services and drug prescriptions. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Knee cap, Patella, Patellofemoral