RecruitingNCT05734651

PROMIS Evaluation Study

Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty


Sponsor

Bezirkskrankenhaus St. Johann in Tirol

Enrollment

200 participants

Start Date

Feb 9, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

Total hip arthroplasty (hip replacement surgery) is one of the most successful and common orthopedic procedures, dramatically improving quality of life for patients with severe hip arthritis. The PROMIS stem is a specific hip implant design, and this registry study tracks the functional outcomes and symptom burden of patients who receive it in real-world clinical practice. By systematically collecting standardized patient-reported outcomes (using the PROMIS — Patient-Reported Outcomes Measurement Information System — questionnaire tools), the registry evaluates how well this implant performs over time. All adults 18 or older who undergo primary total hip arthroplasty using the PROMIS stem are eligible to participate. There are no exclusion criteria for this registry — the goal is to capture as comprehensive a real-world dataset as possible. Participants will complete validated questionnaires about their pain, physical function, and quality of life before surgery and at regular follow-up intervals after their hip replacement. No additional procedures beyond routine clinical care are required. This research is important because while clinical trial data on hip implants often comes from highly selected patient populations, registry data reflects how devices perform across the full spectrum of patients who receive them in everyday practice — including elderly, heavier, and more medically complex patients. This real-world evidence is essential for confirming implant safety and effectiveness, identifying rare complications early, and guiding future implant design improvements.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPROMIS Stem

Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)


Locations(1)

BKH St. Johann in Tirol, Department for Orthopedics and Traumatology

Sankt Johann in Tirol, Tyrol, Austria

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05734651


Related Trials