PROMIS Evaluation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PROMIS Stem.
- Who it may be relevant to
- Registry conditions: Hip Arthropathy, Osteoarthritis, Hip, Perthes Disease, Osteonecrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty
Overview
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
- Device PROMIS Stem
Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)
Primary outcome measures
- Stem Migration [Time frame: 20 years]
Secondary outcome measures (1)
- WOMAC Score [Time frame: 20 years]
Eligibility criteria
Inclusion criteria
- Primary total hip arthroplasty with the PROMIS stem
Exclusion criteria
- n/a
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- BKH St. Johann in Tirol, Department for Orthopedics and Traumatology — Sankt Johann in Tirol
Publications
- Wagner M, Neururer S, Dammerer D, Nardelli P, Kaufmann G, Braito M, Brunner A. External validation of the Tyrolean hip arthroplasty registry. J Exp Orthop. 2022 Aug 30;9(1):87. doi: 10.1186/s40634-022-00526-3. PMID 36042064
Identifiers
NCT: NCT05734651 · 1297/2022