Study of Knee Replacements for Patellofemoral Osteoarthritis

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Knee arthroplasty

• Registration Number: NCT01326156
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Primary Completion: 2014-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Isolated PF-OA

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Exclusion Criteria

• Medial or lateral OA

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avon patellofemoral replacement	Knee arthroplasty	Knee arthroplasty with insertion of patellofemoral joint replacement.
PFC Sigma CR total knee replacement	Knee arthroplasty	Knee arthroplasty with total (tricompartmental) knee replacement.

Primary Outcome Measures

Name	Time	Method
Patient-reported outcomes (disease-specific and generic QoL instruments)	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 Outcome Measures

Name	Time	Method
Implant survival, clinician assessment and cost.	10 years	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.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark