PROMIS Evaluation Study

Bezirkskrankenhaus St. Johann in Tirol

Status: Enrolling

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

Treatments: Device: PROMIS Stem

Study type: Observational

Funder types: Other

Identifiers

NCT05734651

1297/2022

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary total hip arthroplasty with the PROMIS stem

Exclusion criteria

• n/a

Trial design

200 participants in 1 patient group

Intervention

Treatment:

Device: PROMIS Stem