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

This study is ongoing, but not recruiting participants.
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: May 2, 2017
Last verified: May 2017
  Purpose
This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.

Condition Intervention
Osteoarthritis, Knee Device: Knee arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 100
Actual Study Start Date: June 2007
Estimated Study Completion Date: October 2024
Primary Completion Date: October 2014 (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:
  • 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)

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Isolated PF-OA

Exclusion Criteria:

  • Medial or lateral OA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326156

Locations
Denmark
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
  More Information

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: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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 August 16, 2017