Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05067543

Perform Humeral System Study

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Stryker Trauma and Extremities · Industry
Sex
All
Age
18 Years
Healthy volunteers
—

Summary

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

Detailed description

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORM™ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORM™ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.

Conditions

Interventions

TypeNameDescription
DEVICETornier Perform Humeral - StemThe PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

Timeline

Start date
2021-09-12
Primary completion
2036-06-30
Completion
2036-12-01
First posted
2021-10-05
Last updated
2026-02-20

Locations

10 sites across 5 countries: United States, Canada, France, Switzerland, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT05067543. Inclusion in this directory is not an endorsement.