Study of Knee Replacements for Patellofemoral Osteoarthritis (PFA/TKR)

November 4, 2020 updated by: University of Aarhus

Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Isolated PF-OA

Exclusion Criteria:

  • Medial or lateral OA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Avon patellofemoral replacement
Knee arthroplasty with insertion of patellofemoral joint replacement.
Device: Knee arthroplasty
Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.
Other Names:
  • PFA: Avon Patellofemoal arthroplasty (Stryker)
  • TKR: PFC Sigma CR arthroplasty (DePuy)
Active Comparator: PFC Sigma CR total knee replacement
Knee arthroplasty with total (tricompartmental) knee replacement.
Device: Knee arthroplasty
Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.
Other Names:
  • PFA: Avon Patellofemoal arthroplasty (Stryker)
  • TKR: PFC Sigma CR arthroplasty (DePuy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported outcomes (disease-specific and generic QoL instruments)
Time Frame: 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival, clinician assessment and cost.
Time Frame: 10 years
Secondary outcome measures relate to implant survival, clinician assessment and cost. Implant survival will be assessed by 5- and 10-year implant survival rates and by analyzing causes for revision surgery. Clinician assessment includes Knee Society Score (stability, range of movement, effusion, tenderness etc.). Assessments of immediate and long-term costs are based on patient diaries, sick leave, use of medical services and drug prescriptions.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

DePuy Orthopaedics
Stryker Nordic

Investigators

  • Principal Investigator: Anders Odgaard, FRCS, DMSc, Dept. of Orthopaedics, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2007

Primary Completion (Actual)

October 1, 2014

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Time Frame

Beginning 6 months and and ending 5 years following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Analytic Code

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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