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RECRUITING
NCT05734651

PROMIS Evaluation Study

Sponsor: Bezirkskrankenhaus St. Johann in Tirol

View on ClinicalTrials.gov

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.

Official title: Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2023-02-09

Completion Date

2042-02-09

Last Updated

2023-02-21

Healthy Volunteers

Not specified

Interventions

DEVICE

PROMIS 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