PROMIS Evaluation Study

Osteoarthritis, Hip Clinical Trial

Official title:

Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734651
• Other study ID #: 1297/2022
• Status: Recruiting
• Start date: February 9, 2023
• Est. completion date: February 9, 2042

Study information

• Verified date: February 2023
• Source: Bezirkskrankenhaus St. Johann in Tirol
• Contact: Moritz Wagner, MD
• Phone: +4350536608167
• Email: moritz.wagner[@]khsj.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 9, 2042
• Est. primary completion date: February 9, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria:

• n/a

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Austria	BKH St. Johann in Tirol, Department for Orthopedics and Traumatology	Sankt Johann In Tirol	Tyrol

Sponsors (2)

Lead Sponsor	Collaborator
Bezirkskrankenhaus St. Johann in Tirol	Tyrolean Arthroplasty Registry

Country where clinical trial is conducted

Austria, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	WOMAC Score	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.	20 years