Clincosm LogoSign in Get a demo

PFA/TKR: Study of Knee Replacements for Patellofemoral Osteoarthritis

Sponsor
University of Aarhus (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01326156
Collaborator
Stryker Nordic (Industry), DePuy Orthopaedics (Industry)
100
Enrollment
1
Location
2
Arms
208
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Knee arthroplasty
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis
Actual Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Oct 1, 2014
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Avon patellofemoral replacement

Knee arthroplasty with insertion of patellofemoral joint replacement.

Device: Knee arthroplasty
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)

    		•
    Active Comparator: PFC Sigma CR total knee replacement

    Knee arthroplasty with total (tricompartmental) knee replacement.

    Device: Knee arthroplasty
    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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Isolated PF-OA
    Exclusion Criteria:
    • Medial or lateral OA

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Denmark

    Sponsors and Collaborators

    • University of Aarhus
    • Stryker Nordic
    • DePuy Orthopaedics

    Investigators

    • Principal Investigator: Anders Odgaard, FRCS, DMSc, Dept. of Orthopaedics, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT01326156
    Other Study ID Numbers:
    • 56789
    First Posted:
    Mar 30, 2011
    Last Update Posted:
    Nov 6, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by University of Aarhus
    Osteoarthritis
    Knee
    Knee cap
    Patella
    Patellofemoral
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Nov 6, 2020