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PROMIS Evaluation Study

PROMIS Evaluation Study

Recruiting
18 years and older
All
Phase N/A

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Overview

A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical.

The purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.

Eligibility

Inclusion Criteria:

  • Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria:

  • n/a

Study details
    Hip Arthropathy
    Osteoarthritis
    Hip
    Perthes Disease
    Osteonecrosis
    Femoral Neck Fractures

NCT05734651

Bezirkskrankenhaus St. Johann in Tirol

26 January 2024

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