PROMIS Evaluation Study

NCT05734651 | Recruiting FDA Device

• 1 other identifier: 1297/2022
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Stem Migration

  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.

  20 years

Secondary Outcomes (1)

• WOMAC Score

  20 years

Study Arms (1)

Intervention

Device: PROMIS Stem

Interventions

PROMIS Stem DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient treated with primary total hip arthroplasty at this department are included.

You may qualify if:

• Primary total hip arthroplasty with the PROMIS stem

You may not qualify if:

• n/a

Sponsors & Collaborators

• Bezirkskrankenhaus St. Johann in Tirol: lead
• Tyrolean Arthroplasty Registry: collaborator

Study Sites (1)

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

Sankt Johann in Tirol, Tyrol, 6380, Austria

RECRUITING

Related Publications (1)

• Wagner M, Neururer S, Dammerer D, Nardelli P, Kaufmann G, Braito M, Brunner A. External validation of the Tyrolean hip arthroplasty registry. J Exp Orthop. 2022 Aug 30;9(1):87. doi: 10.1186/s40634-022-00526-3.

  PMID: 36042064 RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip; Legg-Calve-Perthes Disease; Osteonecrosis; Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Femur Head Necrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Moritz Wagner, MD

CONTACT

+4350536608167; moritz.wagner@khsj.at

Hannes Schönthaler, MD

CONTACT

+435356608369; hannes.schönthale@khsj.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: February 9, 2023
• Primary Completion: February 9, 2026
• Study Completion (Estimated): February 9, 2042
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

AU (1)