PROMIS Evaluation Study

Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Osteonecrosis; Osteoarthritis, Hip; Femoral Neck Fractures; Hip Arthropathy; Perthes Disease
• Intervention / Treatment: Device: PROMIS Stem

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Moritz Wagner, MD; Phone Number: +4350536608167; Email: moritz.wagner@khsj.at
• Study Contact Backup: Name: Hannes Schönthaler, MD; Phone Number: +435356608369; Email: hannes.schönthale@khsj.at

Study Locations

• Austria
  • Tyrol
    • Sankt Johann In Tirol, Tyrol, Austria, 6380
      • Recruiting
      • BKH St. Johann in Tirol, Department for Orthopedics and Traumatology
      • Contact: Moritz Wagner, Dr. med. univ.; Phone Number: +4367762930592; Email: moritz.wagner@khsj.at
      • Contact: Alexander Brunner, Priv.-Doz. Dr. med. univ.; Phone Number: +435352 6068780; Email: alexander.brunner@khsj.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria:

• n/a

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bezirkskrankenhaus St. Johann in Tirol
• Collaborators: Tyrolean Arthroplasty Registry

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Anticipated): February 9, 2026
• Study Completion (Anticipated): February 9, 2042

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Estimate): February 20, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Femoral Fractures; Hip Injuries; Femur Head Necrosis; Osteoarthritis; Hip Fractures; Legg-Calve-Perthes Disease; Osteoarthritis, Hip; Femoral Neck Fractures; Osteonecrosis
• Other Study ID Numbers: 1297/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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