Study of Knee Replacements for Patellofemoral Osteoarthritis

NCT ID: NCT01326156

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2040-10-31

Brief Summary

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This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.

Detailed Description

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Isolated patellofemoral osteoarthritis can be a disabling condition of the knee necessitating knee arthroplasty. It is debated whether total knee replacement or isolated patellofemoral replacement is the better treatment option. This randomized trial attempts to give a qualified answer to the debate by comparing clinical outcome (range of movement, stability, effusion, patellofemoral tracking, tenderness, stair climbing), patient self assessment scores (EQ-5D, Oxford Knee Score, KOOS, SF-36, AKS), complications (infections, revisions), longevity (survival analysis) and cost (direct and indirect) for the two implant types.

The Avon patellofemoral implant has been chosen, as this is the patellofemoral implant with the best documentation. The PFC Sigma CR total knee implant has been chosen as it a current standard implant and market leader.

Conditions

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Osteoarthritis, Knee Patellofemoral Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic, multi-centre, 1:1 parallel-group, randomised controlled trial. Double-blinded for 1st year. PROMs completion without staff involvement. Statistical consultants blinded.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Patients are blinded to treatment allocation for the first year; they are un-blinded at the one-year follow-up. Hospital staff, excluding the surgical team, are likewise blinded. Discharge letters are intended to exclude implant information to ensure general practitioner blinding.

Study Groups

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Avon patellofemoral replacement

Knee arthroplasty with insertion of patellofemoral joint replacement.

Group Type EXPERIMENTAL

Knee arthroplasty

Intervention Type DEVICE

Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.

PFC Sigma CR total knee replacement

Knee arthroplasty with total (tricompartmental) knee replacement.

Group Type ACTIVE_COMPARATOR

Knee arthroplasty

Intervention Type DEVICE

Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.

Interventions

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Knee arthroplasty

Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.

Intervention Type DEVICE

Other Intervention Names

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PFA: Avon Patellofemoal arthroplasty (Stryker) TKR: PFC Sigma CR arthroplasty (DePuy)

Eligibility Criteria

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Inclusion Criteria

* Isolated PF-OA

Exclusion Criteria

* Medial or lateral OA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Nordic

INDUSTRY

Sponsor Role collaborator

DePuy Orthopaedics

INDUSTRY

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Odgaard, FRCS, DMSc

Role: PRINCIPAL_INVESTIGATOR

Dept. of Orthopaedics, Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Martinique VB, Julie H, Snorre S, Soeren R, Kristensen WP, Zahid A, Alex L, Justin C, Anders O. Equivocal Physical Activity Outcomes 10 Years After Patellofemoral vs Total Knee Replacement: Follow-Up of a Previously Reported Randomised Controlled Trial in Isolated Patellofemoral Joint Osteoarthritis. J ISAKOS. 2025 Nov 15:101037. doi: 10.1016/j.jisako.2025.101037. Online ahead of print.

Reference Type RESULT
PMID: 41248881 (View on PubMed)

Odgaard A, Kappel A, Madsen F, Kristensen PW, Stephensen S, Attarzadeh AP. Erratum to: Patellofemoral Arthroplasty Results in Better Time-weighted Patient-reported Outcomes After 6 Years than TKA: A Randomized Controlled Trial. Clin Orthop Relat Res. 2023 Jul 1;481(7):1455-1457. doi: 10.1097/CORR.0000000000002713. Epub 2023 Jun 15. No abstract available.

Reference Type RESULT
PMID: 37352486 (View on PubMed)

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.

Reference Type RESULT
PMID: 35315804 (View on PubMed)

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.

Reference Type RESULT
PMID: 32228074 (View on PubMed)

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.

Reference Type RESULT
PMID: 29529622 (View on PubMed)

Other Identifiers

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56789

Identifier Type: -

Identifier Source: org_study_id

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