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RecruitingNCT05734651

PROMIS Evaluation Study

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Plain-language summary for patients

Trial Parameters

ConditionHip Arthropathy
SponsorBezirkskrankenhaus St. Johann in Tirol
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment200
SexALL
Min Age18 Years
Max AgeN/A
Start Date2023-02-09
Completion2026-02-09
Interventions
PROMIS Stem

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Brief Summary

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 Criteria

Inclusion Criteria: * Primary total hip arthroplasty with the PROMIS stem Exclusion Criteria: * n/a

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