PROMIS Evaluation Study

• Sponsor: Bezirkskrankenhaus St. Johann in Tirol (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05734651
• Collaborator: Tyrolean Arthroplasty Registry (Other)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 228
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Arthropathy; Osteoarthritis, Hip; Perthes Disease; Osteonecrosis; Femoral Neck Fractures	Device: PROMIS Stem

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty
• Actual Study Start Date: Feb 9, 2023
• Anticipated Primary Completion Date: Feb 9, 2026
• Anticipated Study Completion Date: Feb 9, 2042

Arms and Interventions

Arm	Intervention/Treatment
Intervention	Device: PROMIS Stem; Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)

Outcome Measures

Primary Outcome Measures

1. Stem Migration [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 Outcome Measures

1. WOMAC Score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria:

• n/a

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BKH St. Johann in Tirol, Department for Orthopedics and Traumatology	Sankt Johann In Tirol	Tyrol	Austria	6380

Sponsors and Collaborators

• Bezirkskrankenhaus St. Johann in Tirol
• Tyrolean Arthroplasty Registry

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moritz Wagner, Principal Investigator, Bezirkskrankenhaus St. Johann in Tirol
• ClinicalTrials.gov Identifier: NCT05734651
• Other Study ID Numbers: 1297/2022
• First Posted: Feb 21, 2023
• Last Update Posted: Feb 21, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Osteonecrosis; Osteoarthritis, Hip; Legg-Calve-Perthes Disease; Femoral Neck Fractures

Study Results

No Results Posted as of Feb 21, 2023