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PROMIS Evaluation Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 21, 2023 (before its estimated February 9, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT05734651
Lead Sponsor Bezirkskrankenhaus St. Johann in Tirol
Collaborators: Tyrolean Arthroplasty Registry
Conditions
(from sponsor)		 Hip Arthropathy, Osteoarthritis, Hip, Perthes Disease, Osteonecrosis, Femoral Neck Fractures
Related terms Femoral Neck Fractures, Legg-Calve-Perthes Disease, Osteoarthritis, Hip, Osteonecrosis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov