PROMIS Evaluation Study

Recruiting now

Conditions studied: Hip Arthropathy, Osteoarthritis, Hip, Perthes Disease, Osteonecrosis, Femoral Neck Fractures

In brief

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.

Key facts

Study ID

NCT05734651

Run by

Bezirkskrankenhaus St. Johann in Tirol

People needed

200

Starts

2023-02-09

Expected to finish

2042-02-09

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary total hip arthroplasty with the PROMIS stem

You may not qualify if…

• n/a

Where it is running

• BKH St. Johann in Tirol, Department for Orthopedics and Traumatology — Sankt Johann in Tirol, Tyrol, Austria (enrolling)

Full record on ClinicalTrials.gov

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