Study of Knee Replacements for Patellofemoral Osteoarthritis (PFA/TKR)

University of Aarhus

Status: Active, not recruiting

Conditions: Patellofemoral Knee Arthroplasty; Osteoarthritis, Knee

Treatments: Device: Knee arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01326156

56789

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Isolated PF-OA

Exclusion criteria

• Medial or lateral OA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Avon patellofemoral replacement

Experimental group

Description:

Knee arthroplasty with insertion of patellofemoral joint replacement.

Treatment:

Device: Knee arthroplasty

PFC Sigma CR total knee replacement

Active Comparator group

Description:

Knee arthroplasty with total (tricompartmental) knee replacement.

Treatment:

Device: Knee arthroplasty