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Failure Analysis of Patellofemoral Arthroplasty

Failure Analysis of Patellofemoral Arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04772625
Enrollment
550
Registered
2021-02-26
Start date
2019-01-01
Completion date
2026-04-01
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications, Knee Osteoarthritis, Patellofemoral Osteoarthritis

Keywords

Patellofemoral arthroplasty, Knee revision surgery, Indication

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.

Interventions

Insertion of an artificial joint between the front of the femur and the back of the patella. The femoral component consists of a metal implant, and the patellar component is a polyethylene implant. The two components replace the original articular cartilage of the patellofemoral joint.

Sponsors

Stryker Orthopaedics
CollaboratorINDUSTRY
Anders Odgaard
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Implant revision and reoperation rates10-yearThe proportion of revised and reoperated patients

Secondary

MeasureTime frameDescription
The 6-year cumulative revision rate6 yearsThe 6-year cumulative revision rate of patellofemoral arthroplasties in a target trial comparing two groups of surgeons: 1) those surgeons, who were a part of a randomised clinical trial comparing PFA and TKA, and 2) other surgeons. In addition to this, the 6-year cumulative reoperation rate (other than revision) and the 6-year cumulative mortality rate will also be reported.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026