NCT05773352

Perform® Humeral System - Fracture Study (PFX)

Tornier Perform® Humeral System - Fracture Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 118 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, intra operative, and 6 months data can be collected retrospectively up to 12 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.

Conditions

• Traumatic Arthropathy of Shoulder
• Fracture Humerus
• Traumatic Arthritis
• Revision of Other Devices if Sufficient Bone Stock Remains

Interventions

Type	Name	Description
DEVICE	Tornier Perform® Humeral System - Fracture	A replacement of shoulder joints for anatomic and reverse shoulder arthroplasty. A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

Timeline

• Start date: 2023-08-31
• Primary completion: 2026-10-01
• Completion: 2034-09-01
• First posted: 2023-03-17
• Last updated: 2026-04-15

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study