Trials / Recruiting
RecruitingNCT05734651
PROMIS Evaluation Study
Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Bezirkskrankenhaus St. Johann in Tirol · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PROMIS Stem | Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria) |
Timeline
- Start date
- 2023-02-09
- Primary completion
- 2026-02-09
- Completion
- 2042-02-09
- First posted
- 2023-02-21
- Last updated
- 2023-02-21
Locations
1 site across 1 country: Austria
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05734651. Inclusion in this directory is not an endorsement.