RecruitingNCT05734651

PROMIS Evaluation Study

Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty


Sponsor

Bezirkskrankenhaus St. Johann in Tirol

Enrollment

200 participants

Start Date

Feb 9, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria1

  • n/a

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Interventions

DEVICEPROMIS Stem

Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)


Locations(1)

BKH St. Johann in Tirol, Department for Orthopedics and Traumatology

Sankt Johann in Tirol, Tyrol, Austria

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NCT05734651


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