Onlay vs. Inlay Patellofemoral Arthroplasty

NCT ID: NCT02912429

Last Updated: 2016-09-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Patellofemoral Joint Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Inlay

specific technical type of patellofemoral arthroplasty

Group Type OTHER

Patellofemoral Arthroplasty

Intervention Type DEVICE

Onlay

specific technical type of patellofemoral arthroplasty

Group Type OTHER

Patellofemoral Arthroplasty

Intervention Type DEVICE

Interventions

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Patellofemoral Arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Michael Liebensteiner

Principal Investigator and Coordinating Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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michael liebensteiner

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

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Medical University Innsbruck

Innsbruck, Tyrol, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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michael C Liebensteiner

Role: CONTACT

+43 512 504 ext. 80547

Facility Contacts

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Michael C Liebensteiner, Professor

Role: primary

+43 512 504 80547

Other Identifiers

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PF-Arthroplasty 1

Identifier Type: -

Identifier Source: org_study_id

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