Overview

This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatment knee arthroplasty
Phase phase 4
Sponsor University of Aarhus
Collaborator Stryker Nordic
Start date June 2007
End date November 2015
Trial size 100 participants
Trial identifier NCT01326156, 56789

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Knee arthroplasty with insertion of patellofemoral joint replacement.
knee arthroplasty PFA: Avon Patellofemoal arthroplasty (Stryker)
Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.
(Active Comparator)
Knee arthroplasty with total (tricompartmental) knee replacement.
knee arthroplasty PFA: Avon Patellofemoal arthroplasty (Stryker)
Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.

Primary Outcomes

Measure
Patient-reported outcomes (disease-specific and generic QoL instruments)
time frame: 10 years

Secondary Outcomes

Measure
Implant survival, clinician assessment and cost.
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis
Principal investigator Anders Odgaard, FRCS, DMSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Aarhus.