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Clinical Trials/NCT01326156
NCT01326156
Active, Not Recruiting
N/A

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

University of Aarhus1 site in 1 country100 target enrollmentJune 1, 2007
InterventionsKnee arthroplasty

Overview

Phase
N/A
Intervention
Knee arthroplasty
Conditions
Not specified
Sponsor
University of Aarhus
Enrollment
100
Locations
1
Primary Endpoint
Patient-reported outcomes (disease-specific and generic QoL instruments)
Status
Active, Not Recruiting
Last Updated
3 months ago

Overview

Brief Summary

This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2007
End Date
October 1, 2040
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Isolated PF-OA

Exclusion Criteria

  • Medial or lateral OA

Arms & Interventions

Avon patellofemoral replacement

Knee arthroplasty with insertion of patellofemoral joint replacement.

Intervention: Knee arthroplasty

PFC Sigma CR total knee replacement

Knee arthroplasty with total (tricompartmental) knee replacement.

Intervention: Knee arthroplasty

Outcomes

Primary Outcomes

Patient-reported outcomes (disease-specific and generic QoL instruments)

Time Frame: 10 years

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).

Secondary Outcomes

  • Implant survival, clinician assessment and cost.(10 years)

Study Sites (1)

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