NCT04772625

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2022

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3.9 years

First QC Date

February 24, 2021

Last Update Submit

July 25, 2025

Conditions

Keywords

Patellofemoral arthroplastyKnee revision surgeryIndication

Outcome Measures

Primary Outcomes (1)

  • Implant revision and reoperation rates

    The proportion of revised and reoperated patients

    10-year

Secondary Outcomes (1)

  • The 6-year cumulative revision rate

    6 years

Study Arms (1)

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.

Device: Patellofemoral arthroplasty

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.

Also known as: Artificial joint between knee cap and thigh bone
PFA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated with patellofemoral arthroplasty for patellofemoral osteoarthritis.

You may qualify if:

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

You may not qualify if:

  • Patella-nail syndrome
  • Dislocating tendon following patellectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (6)

  • 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.

    PMID: 29529622BACKGROUND
  • 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.

    PMID: 31259645BACKGROUND
  • 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.

    PMID: 31579533BACKGROUND
  • 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.

    PMID: 32228074BACKGROUND
  • 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.

    PMID: 35315804BACKGROUND
  • 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.

    PMID: 40577013BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Anders Odgaard, MD, DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2021

First Posted

February 26, 2021

Study Start

January 1, 2019

Primary Completion

November 9, 2022

Study Completion

April 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07

Locations