An observational study in Hip Arthropathy, Osteoarthritis, Hip and Perthes Disease, sponsored by Bezirkskrankenhaus St. Johann in Tirol. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Bezirkskrankenhaus St. Johann in Tirol · Observational
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.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 200 is above the median of 135 across 158 observational studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Bezirkskrankenhaus St. Johann in Tirol is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient treated with primary total hip arthroplasty at this department are included.
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Exclusion Criteria:
Device: PROMIS Stem
Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)
Stem Migration
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.
Time frame: 20 years
WOMAC Score
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.
Time frame: 20 years
Plan to share: Undecided
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Bezirkskrankenhaus St. Johann in Tirol