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PROMIS Evaluation Study

NCT05734651 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-02-21

No results posted yet for this study

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.

Conditions

  • Hip Arthropathy
  • Osteoarthritis, Hip
  • Perthes Disease
  • Osteonecrosis
  • Femoral Neck Fractures

Interventions

DEVICE

PROMIS Stem

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

Sponsors & Collaborators

  • Tyrolean Arthroplasty Registry

    collaborator UNKNOWN

  • Bezirkskrankenhaus St. Johann in Tirol

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2026-02-09
Completion
2042-02-09
FDA Device
Yes

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05734651 on ClinicalTrials.gov