Perform® Humeral System - Fracture Study (PFX) — PFX  

Traumatic Arthritis Clinical Trial

Official title: Tornier Perform® Humeral System - Fracture Study

Status Recruiting

Clinical Trial Summary

This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture.

Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.

Clinical Trial Description

This is an International, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Perform® Fracture shoulder system in both the anatomic and reversed configurations.

The primary endpoint of this study is to demonstrate decreased pain and improved subjects' shoulder functionality of daily living by achieving a mean of American Shoulder and Elbow Surgeons (ASES) shoulder score higher than 62 points, at 2-year follow-up post-operatively, regardless of configuration (anatomic or reverse).

Retrospective inclusions are allowed: preoperative and intra operative data can be collected retrospectively up to 2 months after the surgery date.

Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification.

Safety and performance data will be collected at surgery, immediate post-op, and up to 10 years post-operation. Patient Reported Outcome Measures (PROMs), device revision and Adverse Events (AEs) will be assessed annually throughout the study.

Range of Motion (ROM), strength and radiographic imaging assessments of the study shoulder will also be performed for in-person milestones visits at 6 months (radiographic imaging assessments), 1-, 2-, 5- and 10-year, post-operatively. ;

Related Conditions & MeSH terms

• Fracture Humerus
• Fractures, Bone
• Humeral Fractures
• Traumatic Arthritis

• NCT number: NCT05773352
• Study type: Observational
• Source: Stryker Trauma GmbH
• Contact: Monica Fleeman
• Phone: 251-465-5969
• Email: monica.fleeman@stryker.com
• Status: Recruiting
• Start date: August 31, 2023
• Completion date: September 1, 2033