Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT01326156

Study of Knee Replacements for Patellofemoral Osteoarthritis

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis, Knee Arthritis Fractures, Bone Joint Diseases Knee Fractures Musculoskeletal Diseases Osteoarthritis Patella Fracture Patellofemoral Knee Arthroplasty Rheumatic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Isolated PF-OA

Exclusion criteria

  • Medial or lateral OA

Treatment and study plan

Knee arthroplasty

Device

Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.

Other names: PFA: Avon Patellofemoal arthroplasty (Stryker), TKR: PFC Sigma CR arthroplasty (DePuy)

Primary outcomes

  1. 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

  1. Implant survival, clinician assessment and cost.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • DePuy Orthopaedics
  • Rigshospitalet, Denmark
  • Stryker Nordic

Registry information

Official study title

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

Acronym: PFA/TKR

Important dates

Study start
2007
Primary completion
2025
Study completion
2040
First posted
Mar 30, 2011
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.