Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hip Arthropathy
- Sponsor
- Bezirkskrankenhaus St. Johann in Tirol
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Stem Migration
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Moritz Wagner
Principal Investigator
Bezirkskrankenhaus St. Johann in Tirol
Eligibility Criteria
Inclusion Criteria
- •Primary total hip arthroplasty with the PROMIS stem
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Stem Migration
Time Frame: 20 years
Stem Migration measured with the validated EBRA method. The stem migration is assessed in millimeters. The radiograph before surgery and sequential radiographs after surgery are assessed.
Secondary Outcomes
- WOMAC Score(20 years)