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NCT Number: NCT05734651

PROMIS Evaluation Study

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.

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Key information

Conditions

Hip Arthropathy Arthritis Bone Diseases Femoral Fractures Femoral Neck Fractures Femur Head Necrosis Fractures, Bone Hip Fractures Hip Injuries Joint Diseases Leg Injuries Legg-Calve-Perthes Disease Musculoskeletal Diseases Necrosis Osteoarthritis Osteoarthritis, Hip Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Perthes Disease Rheumatic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary total hip arthroplasty with the PROMIS stem

Exclusion criteria

  • n/a

Treatment and study plan

PROMIS Stem

Device

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

Primary outcomes

  1. Stem Migration

    Time frame: 20 years

    Stem Migration measured with the validated EBRA method. The stem migration is assessed in millimeters. The radiograph before surgery and sequential radiographs after surgery are assessed.

Secondary outcomes

  1. WOMAC Score

    Time frame: 20 years

    Patient reported outcome score that is assessed before the surgery and one year after the surgery, 5 years after the surgery, 10 years and 20 years after the surgey.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannes Schönthaler, MD

CONTACT

hannes.schö[email protected]

+435356608369

Moritz Wagner, MD

CONTACT

[email protected]

+4350536608167

Sponsors and collaborators

Lead sponsor

Bezirkskrankenhaus St. Johann in Tirol

Other

Collaborators

  • Tyrolean Arthroplasty Registry

Registry information

Official study title

Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty

Important dates

Study start
2023
Primary completion
2026
Study completion
2042
First posted
Feb 21, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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