Actively Recruiting
PROMIS Evaluation Study
Led by Bezirkskrankenhaus St. Johann in Tirol · Updated on 2023-02-21
200
Participants Needed
1
Research Sites
991 weeks
Total Duration
On this page
Sponsors
B
Bezirkskrankenhaus St. Johann in Tirol
Lead Sponsor
T
Tyrolean Arthroplasty Registry
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PROMIS Evaluation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary total hip arthroplasty with the PROMIS stem
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BKH St. Johann in Tirol, Department for Orthopedics and Traumatology
Sankt Johann in Tirol, Tyrol, Austria, 6380
Actively Recruiting
Research Team
M
Moritz Wagner, MD
CONTACT
H
Hannes Schönthaler, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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