Actively Recruiting
Study Evaluating the Safety and Effectiveness of the PROMIS Stem Implant for Primary Total Hip Replacement
Led by Bezirkskrankenhaus St. Johann in Tirol · Updated on 2023-02-21
200
Participants Needed
1
Research Sites
834 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of implants produced and distributed by Falcon Medical, specifically focusing on the PROMIS Stem used in primary total hip arthroplasty THA. The study includes patients undergoing primary THA with Falcon Medical implants to monitor their clinical performance and improvements over time. Participants will receive primary total hip arthroplasty using the PROMIS Stem implant from Falcon Medical. This observational study collects data prospectively in a standardized manner without additional interventions or comparator groups. The study evaluates outcomes related to the implants performance during and after surgery. Participants will be followed for up to 20 years to assess outcomes such as stem migration and patient-reported outcomes measured by the WOMAC questionnaire. Data on intra-operative and early post-operative complications, as well as any revisions, will be collected. This long-term monitoring helps researchers understand the implants safety and efficacy.
CONDITIONS
Brief Title
PROMIS Evaluation Study
Research Team
M
Moritz Wagner, MD
H
Hannes Schönthaler, MD
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