Study of Knee Replacements for Patellofemoral Osteoarthritis (PFA/TKR)
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Purpose
This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee |
Device: Knee arthroplasty |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis |
- Patient-reported outcomes (disease-specific and generic QoL instruments) [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]Patient reported outcomes are the primary outcomes of the study. These include general QoL measures (SF-36 and EQ5D) and disease specific outcome measures (Oxford Knee Score, KOOS, Kujala).
- Implant survival, clinician assessment and cost. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2022 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Isolated PF-OA
Exclusion Criteria:
- Medial or lateral OA
Contacts and Locations| Contact: Anders Odgaard, FRCS, DMSc | +45 8949 7575 | ao@knee.dk |
| Denmark | |
| Aarhus University Hospital | Recruiting |
| Aarhus, Denmark | |
| Principal Investigator: Anders Odgaard, FRCS, DMSc | |
| Principal Investigator: | Anders Odgaard, FRCS, DMSc | Dept. of Orthopaedics, Aarhus University Hospital |
More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01326156 History of Changes |
| Other Study ID Numbers: | 56789 |
| Study First Received: | May 19, 2009 |
| Last Updated: | March 20, 2012 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by University of Aarhus:
|
Osteoarthritis Knee Knee cap Patella Patellofemoral |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013