Femoral Neck Fractures, Hip Arthropathy, Osteoarthritis, Hip, Osteonecrosis, Perthes Disease
Conditions
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.
Interventions
DEVICEPROMIS Stem
Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)
Sponsors
Tyrolean Arthroplasty Registry
Bezirkskrankenhaus St. Johann in Tirol
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Primary total hip arthroplasty with the PROMIS stem
Exclusion criteria
* n/a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stem Migration | 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
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Score | 20 years | Patient reported outcome score that is assessed before the surgery and one year after the surgery, 5 years after the surgery, 10 years and 20 years after the surgey. |
Countries
Austria
Contacts
Primary ContactMoritz Wagner, MD
Backup ContactHannes Schönthaler, MD
Outcome results
None listed