NCT01326156

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
175mo left

Started Jun 2007

Longer than P75 for not_applicable

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 Progress57%
Jun 2007Oct 2040

Study Start

First participant enrolled

June 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
15.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2040

Expected
Last Updated

January 8, 2026

Status Verified

November 1, 2020

Enrollment Period

17.8 years

First QC Date

May 19, 2009

Last Update Submit

January 5, 2026

Conditions

Osteoarthritis, KneePatellofemoral Knee Arthroplasty

Keywords

OsteoarthritisKneeKnee capPatellaPatellofemoral

Outcome Measures

Primary Outcomes (1)

  • Patient-reported outcomes (disease-specific and generic QoL instruments)

    The physical functioning score of the Short Form (36) Health Survey is the primary outcome measure of the study. Disease-specific patient-reported outcomes (Oxford Knee Score, KOOS and Kujala) and a second generic quality of life measure (EQ5D).

    10 years

Secondary Outcomes (1)

  • Implant survival, clinician assessment and cost.

    10 years

Study Arms (2)

Avon patellofemoral replacement

EXPERIMENTAL

Knee arthroplasty with insertion of patellofemoral joint replacement.

Device: Knee arthroplasty

PFC Sigma CR total knee replacement

ACTIVE COMPARATOR

Knee arthroplasty with total (tricompartmental) knee replacement.

Device: Knee arthroplasty

Interventions

Knee arthroplastyDEVICE

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

Also known as: PFA: Avon Patellofemoal arthroplasty (Stryker), TKR: PFC Sigma CR arthroplasty (DePuy)
Avon patellofemoral replacementPFC Sigma CR total knee replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated PF-OA

You may not qualify if:

  • Medial or lateral OA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

Related Publications (5)

  • 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 randomized controlled trial in isolated patellofemoral joint osteoarthritis. J ISAKOS. 2025 Nov 15;17:101037. doi: 10.1016/j.jisako.2025.101037. Online ahead of print.

    PMID: 41248881RESULT

  • 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.

    PMID: 37352486RESULT

  • 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: 35315804RESULT

  • 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: 32228074RESULT

  • 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: 29529622RESULT

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPatella Fracture

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesKnee FracturesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Anders Odgaard, FRCS, DMSc

    Dept. of Orthopaedics, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic, multi-centre, 1:1 parallel-group, randomised controlled trial. Double-blinded for 1st year. PROMs completion without staff involvement. Statistical consultants blinded.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

March 30, 2011

Study Start

June 1, 2007

Primary Completion

April 1, 2025

Study Completion (Estimated)

October 1, 2040

Last Updated

January 8, 2026

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

IPD that underlie the results reported in published article, after deidentification (text, tables, figures and appendices).

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Beginning 6 months and and ending 5 years following article publication.
Access Criteria
For investigators whose proposed use of the data has been approved by and independent review committee identified for this purpose or for researchers who provide a methdologically sound proposal. Types of analyses accepted: For acheiving aims of the approved proposal. Proposals should be directed to anders.odgaard@regionh.dk. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years following publication at a third party website.

Locations

DK(1)