Evaluation of Falcon Medical hip implants in total hip arthroplasty
Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty
This study is testing how safe and effective Falcon Medical hip implants are for people getting new hips through surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bezirkskrankenhaus St. Johann in Tirol Academic / other |
| Locations | 1 site (Sankt Johann in Tirol, Tyrol) |
| Trial ID | NCT05734651 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and efficacy of hip implants produced by Falcon Medical in patients undergoing primary total hip arthroplasty (THA). A total of 250 surgeries will be performed at Bezirkskrankenhaus St. Johann, with data collected on intra-operative and early post-operative complications, as well as patient-reported outcomes using the WOMAC questionnaire. The study aims to ensure the clinical performance of these implants through standardized prospective data collection.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for primary total hip arthroplasty using a Falcon Medical implant.
Not a fit: Patients who are not undergoing total hip arthroplasty or are using implants from other manufacturers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of hip implants, leading to improved outcomes for patients undergoing hip replacement surgery.
How similar studies have performed: Other studies evaluating the safety and efficacy of orthopedic implants have shown success, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary total hip arthroplasty with the PROMIS stem Exclusion Criteria: * n/a
Where this trial is running
Sankt Johann in Tirol, Tyrol
- BKH St. Johann in Tirol, Department for Orthopedics and Traumatology — Sankt Johann in Tirol, Tyrol, Austria (Recruiting)
Study contacts
- Study coordinator: Moritz Wagner, MD
- Email: moritz.wagner@khsj.at
- Phone: +4350536608167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.