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Clinical Trials/NCT04772625
NCT04772625
Active, not recruiting
Not Applicable

Failure Analysis of Patellofemoral Arthroplasty

Anders Odgaard1 site in 1 country550 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellofemoral Osteoarthritis
Sponsor
Anders Odgaard
Enrollment
550
Locations
1
Primary Endpoint
Implant revision and reoperation rates
Status
Active, not recruiting
Last Updated
9 months ago

Overview

Brief Summary

The purpose of the retrospective cohort study is 1) to determine preoperative risk factors for revision af patellofemoral arthroplasty, and 2) to provide a detailed description of indications for revision after patellofemoral arthroplasty. All patients operated with patellofemoral arthroplasty in Denmark from January 1, 2008 to December 31, 2015, will be included in the cohort.

Detailed Description

Approx. 11,000 operations with the insertion of a knee arthroplasty (knee prosthesis) are performed annually DK. The durability and quality of the treatment are assessed with prosthesis survival, that expresses the proportion of prostheses that are still functional after a given number of years (eg the 10-year prosthesis survival for all types of knee prostheses in DK is approximately 94%). Unicompartmental implants are increasingly used, so that only the worn part of the knee is replaced. Especially for osteoarthritis between the patella and the femur, a patellofemoral prosthesis (PFA - patellofemoral alloplasty) can be inserted, which is much smaller than the traditional full prosthesis (TKA - total knee arthroplasty). PFA operations are controversial. A recently published Danish study (double-blind RCT) comparing TKA and PFA has shown that PFA patients achieve greater satisfaction, better knee function and greater quality of life than TKA patients. A recent study has also demonstrated that the cost of a PFA procedure is less than that of a TKA. As a paradox to this clear RCT finding, all national implant registers (Sweden, England, New Zealand, Denmark, etc.) show a significantly poorer prosthesis survival for PFA compared with TKA. It is important for the future treatment of patients with severe osteoarthritis between the patella and femur to understand the cause of the discrepancy between RCT and registry results. The discrepancy gives rise to a number of questions regarding. indications, techniques, competences, postoperative regimens etc. The divergence between the RCT and registry studies can only be clarified by a study that 1) examines the influence of preperative factors (patient history, physical findings, radiology etc.) on outcome, and that 2) attempts a causal analysis for each reoperation. The investigators intend to do this though a cohort study including all cases of patellofemoral arthroplasty performed in Denmark from January 1, 2008 until December 31, 2015. The purpose is to determine preoperative risk factors for revision after PFA and to provide a detailed description of indications for revision after PFA.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
April 1, 2026
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Anders Odgaard
Responsible Party
Sponsor Investigator
Principal Investigator

Anders Odgaard

Professor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Patellofemoral arthroplasty
  • Primary procedure performed between Jan 1 2008 and Dec 31 2015
  • Primary procedure performed in Denmark

Exclusion Criteria

  • Patella-nail syndrome
  • Dislocating tendon following patellectomy.

Outcomes

Primary Outcomes

Implant revision and reoperation rates

Time Frame: 10-year

The proportion of revised and reoperated patients

Secondary Outcomes

  • The 6-year cumulative revision rate(6 years)

Study Sites (1)

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