Failure Analysis of Patellofemoral Arthroplasty

• ClinicalTrials.gov Identifier: NCT04772625
• Recruitment Status: Active, not recruiting
• First Posted: February 26, 2021
• Last Update Posted: April 1, 2021
• Sponsor: Anders Odgaard
• Collaborator: Stryker Orthopaedics
• Information provided by (Responsible Party): Anders Odgaard, Rigshospitalet, Denmark

Study Description

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.

Condition or disease	Intervention/treatment
Patellofemoral Osteoarthritis; Arthroplasty Complications; Knee Osteoarthritis	Procedure: Patellofemoral arthroplasty

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 550 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Failure Analysis of Patellofemoral Arthroplasty
• Actual Study Start Date: January 1, 2019
• Estimated Primary Completion Date: April 1, 2021
• Estimated Study Completion Date: April 1, 2022

Groups and Cohorts

Group/Cohort

Intervention/treatment

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.

Procedure: 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 Name: Artificial joint between knee cap and thigh bone

Outcome Measures

Primary Outcome Measures :

1. Implant revision and reoperation rates [ Time Frame: 10-year ]
   The proportion of revised and reoperated patients

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients operated with patellofemoral arthroplasty for patellofemoral osteoarthritis.

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.

Contacts and Locations

Locations

Denmark

Rigshospitalet

Copenhagen, Denmark, 2100

Sponsors and Collaborators

Anders Odgaard

Stryker Orthopaedics

Investigators

• Principal Investigator: Anders Odgaard, MD, DMSc; Rigshospitalet, Denmark

More Information

Publications:

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. Erratum in: JBJS Essent Surg Tech. 2020 Jul 09;10(3):.

Fredborg C, Odgaard A, Sørensen 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.

• Responsible Party: Anders Odgaard, Professor, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT04772625
• Other Study ID Numbers: PFA_Failure_06
• First Posted: February 26, 2021
• Last Update Posted: April 1, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Anders Odgaard, Rigshospitalet, Denmark:

Patellofemoral arthroplasty; Knee revision surgery; Indication

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases