PROMIS Evaluation Study
Recruiting · NCT05734651 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bezirkskrankenhaus St. Johann in Tirol
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Primary total hip arthroplasty with the PROMIS stem
Exclusion criteria
- n/a
Where it is running
1 location listed.
- BKH St. Johann in Tirol, Department for Orthopedics and Traumatology - Sankt Johann in Tirol, Tyrol, Austria