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

This study is currently recruiting participants.
Verified March 2012 by University of Aarhus
Sponsor:
Collaborators:
Stryker Nordic
DePuy Orthopaedics
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01326156
First received: May 19, 2009
Last updated: March 20, 2012
Last verified: March 2012
History of Changes

May 19, 2009
March 20, 2012
June 2007
June 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01326156 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of Knee Replacements for Patellofemoral Osteoarthritis
Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis

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

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis, Knee
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)
  • Experimental: Avon patellofemoral replacement
    Knee arthroplasty with insertion of patellofemoral joint replacement.
    Intervention: Device: Knee arthroplasty
  • Active Comparator: PFC Sigma CR total knee replacement
    Knee arthroplasty with total (tricompartmental) knee replacement.
    Intervention: Device: Knee arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2022
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Isolated PF-OA

Exclusion Criteria:

  • Medial or lateral OA
Both
18 Years and older
No
Contact: Anders Odgaard, FRCS, DMSc +45 8949 7575 ao@knee.dk
Denmark
 
NCT01326156
56789
No
University of Aarhus
University of Aarhus
  • Stryker Nordic
  • DePuy Orthopaedics
Principal Investigator: Anders Odgaard, FRCS, DMSc Dept. of Orthopaedics, Aarhus University Hospital
University of Aarhus
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP