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PROMIS Evaluation Study
Sponsor: Bezirkskrankenhaus St. Johann in Tirol
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
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