Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
550 participants
OBSERVATIONAL
2019-01-01
2026-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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PFA
The cohort consists of all patients operated with patellofemoral arthroplasty for isolated patellofemoral osteoarthritis in Denmark from Jan 1 2008 to Dec 31 2015. The number of patients is expected to be around 500. A patellofemoral arthroplasty is defined as an arthroplasty consisting of a metal trochlear component and a polyethylene patella component. The definition of isolated patellofemoral osteoarthritis in the study is pragmatic and given by the operating surgeon.
Patellofemoral arthroplasty
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.
Interventions
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Patellofemoral arthroplasty
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary procedure performed between Jan 1 2008 and Dec 31 2015
* Primary procedure performed in Denmark
Exclusion Criteria
* Dislocating tendon following patellectomy.
ALL
No
Sponsors
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Stryker Orthopaedics
INDUSTRY
Anders Odgaard
OTHER
Responsible Party
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Anders Odgaard
Professor
Principal Investigators
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Anders Odgaard, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Odgaard A, Madsen F, Kristensen PW, Kappel A, Fabrin J. The Mark Coventry Award: Patellofemoral Arthroplasty Results in Better Range of Movement and Early Patient-reported Outcomes Than TKA. Clin Orthop Relat Res. 2018 Jan;476(1):87-100. doi: 10.1007/s11999.0000000000000017.
Bendixen NB, Eskelund PW, Odgaard A. Failure modes of patellofemoral arthroplasty-registries vs. clinical studies: a systematic review. Acta Orthop. 2019 Oct;90(5):473-478. doi: 10.1080/17453674.2019.1634865. Epub 2019 Jul 1.
Odgaard A, Eldridge J, Madsen F. Patellofemoral Arthroplasty. JBJS Essent Surg Tech. 2019 Apr 24;9(2):e15. doi: 10.2106/JBJS.ST.18.00094. eCollection 2019 Jun 26.
Fredborg C, Odgaard A, Sorensen J. Patellofemoral arthroplasty is cheaper and more effective in the short term than total knee arthroplasty for isolated patellofemoral osteoarthritis: cost-effectiveness analysis based on a randomized trial. Bone Joint J. 2020 Apr;102-B(4):449-457. doi: 10.1302/0301-620X.102B4.BJJ-2018-1580.R3.
Odgaard A, Kappel A, Madsen F, Kristensen PW, Stephensen S, Attarzadeh AP. Patellofemoral Arthroplasty Results in Better Time-weighted Patient-reported Outcomes After 6 Years than TKA: A Randomized Controlled Trial. Clin Orthop Relat Res. 2022 Sep 1;480(9):1707-1718. doi: 10.1097/CORR.0000000000002178. Epub 2022 Mar 21.
Rasmussen LE, Hoffmann AG, Blanche P, Espersen F, Justesen TF, Rasmussen LE, Hangaard S, Christensen R, Odgaard A. Surgeon Training and Revision Rates After Patellofemoral Arthroplasty. JAMA Netw Open. 2025 Jun 2;8(6):e2517825. doi: 10.1001/jamanetworkopen.2025.17825.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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PFA_Failure_06
Identifier Type: -
Identifier Source: org_study_id
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