Onlay vs. Inlay Patellofemoral Arthroplasty

September 26, 2016 updated by: Michael Liebensteiner, Medical University Innsbruck

Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study

There is currently no sufficient evidence if there is superiority of one of the two available types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of this study to compare the two types in a prospective comparative setting. Patients on the waiting list for patellofemoral arthroplasty are randomized to either onlay or inlay type patellofemoral arthroplasty. The KOOS - knee score serves as the primary outcome parameter. Secondary outcome parameters are the Marx Activity Scale, the HSS patella score, the Kujala Score, radiographic loosening, progression of tibiofemoral degeneration, revision surgery and parameters of patellofemoral tracking. Inferential statistics will be performed at 1-year follow up data-sets.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

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 Contact

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Medical University Innsbruck
        • Contact:
        • Principal Investigator:
          • Michael C Liebensteiner

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 to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty

Exclusion Criteria:

  • systemic inflammatory arthropathy
  • tibiofemoral joint degeneration IKDC grade C or worse
  • severe degeneration of also the trochlea margins (inlay PFA not adequate)
  • patellectomy
  • previous implantation of tibiofemoral metal implants
  • extension loss >5 degree
  • knee flexion of less than 100°
  • planned concomitant tibiofemoral procedures (eg. coronal plane osteotomies, tibiofemoral cartilage procedures, tibiofemoral ligament procedures)

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Inlay
specific technical type of patellofemoral arthroplasty
Device: Patellofemoral Arthroplasty
OTHER: Onlay
specific technical type of patellofemoral arthroplasty
Device: Patellofemoral Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
KOOS knee score
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Kujala Score
Time Frame: 1 year
1 year
Marx Activity Scale
Time Frame: 1 year
1 year
HSS patella Score
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiolucent lines adjacent to the prosthesis
Time Frame: 20 years
radiolucent lines adjacent to the prosthesis indicate prosthesis loosening
20 years
revision of prosthesis
Time Frame: 20 years
reoperations with ex/implantation of implants are defined as prosthetic revision
20 years
progression of tibiofemoral osteoarthritis
Time Frame: 20 years
progression of tibiofemoral osteoarthritis is assessed in terms of IKDC grades A-D
20 years

Collaborators and Investigators

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

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: michael liebensteiner, Medical University Innsbruck

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

September 1, 2016

Primary Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (ESTIMATE)

September 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF-Arthroplasty 1

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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