PROMIS Evaluation Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBezirkskrankenhaus St. Johann in Tirol

About this trial

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.

Eligibility criteria

Qualifiers

Primary total hip arthroplasty with the PROMIS stem

Disqualifiers

n/a

Trial design

Treatments tested in this trial

  • PROMIS Stem

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bezirkskrankenhaus St. Johann in Tirol

Lead sponsor

Tyrolean Arthroplasty Registry

Collaborator