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Active, not recruitingNCT04772625Updated Jul 30, 2025

Failure Analysis of Patellofemoral Arthroplasty

An observational study in Patellofemoral Osteoarthritis, Arthroplasty Complications and Knee Osteoarthritis, sponsored by Anders Odgaard. Active, not recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by Anders Odgaard · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
550
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patellofemoral Osteoarthritis
  • Arthroplasty Complications
  • Knee Osteoarthritis

Keywords

  • Patellofemoral arthroplasty
  • Knee revision surgery
  • Indication
03

In context

Osteoarthritis, Knee

3,303 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 550 is above the median of 100 across 473 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

This is the only study on the registry with Anders Odgaard as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients operated with patellofemoral arthroplasty for patellofemoral osteoarthritis.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patella-nail syndrome
  • Dislocating tendon following patellectomy.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
550 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DevicePatellofemoral 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.

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

06

What researchers measure

Primary outcomes

  1. Implant revision and reoperation rates

    The proportion of revised and reoperated patients

    Time frame: 10-year

Secondary outcomes

  1. The 6-year cumulative revision rate

    The 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.

    Time frame: 6 years

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
08

References and documents

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. PubMed 29529622 ↗
  • 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. PubMed 31259645 ↗
  • 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. PubMed 31579533 ↗
  • 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. PubMed 32228074 ↗
  • 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. PubMed 35315804 ↗
  • 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. PubMed 40577013 ↗

Study documents

  • Statistical analysis plan · Aug 28, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04772625
Lead sponsor
Anders Odgaard
Collaborators
Stryker Orthopaedics
Responsible party
Anders Odgaard (Professor, Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Feb 26, 2021
Start date
Jan 1, 2019
Primary completion
Nov 9, 2022
Completion
Apr 1, 2026 (estimated)
Last update
Jul 30, 2025

Study contacts

Anders Odgaard, MD, DMSc
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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