Perform® Humeral System - Fracture Study (PFX)

NCT ID: NCT05773352

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2033-09-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tornier Perform® Humeral System - Fracture

Commercially available convertible humeral system for anatomic and reverse shoulder arthroplasty.

Tornier Perform® Humeral System - Fracture

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years or older at the time of the informed consent or the non-opposition (when applicable)
• Informed and willing to sign an informed consent form (ICF) approved by IRB or EC (when applicable)
• Willing and able to comply with the requirements of the study protocol
• Considered a candidate for shoulder arthroplasty with the device for shoulder joint disabled by:

• Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures
• Fracture sequelae
• Revisions where adequate fixation can be achieved, and adequate bone stock remains after final reconstruction
• Proximal humerus bone defect (reverse configuration)

Exclusion Criteria

• Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
• Patient belongs to a vulnerable group of subjects, including minor subjects, those unable to decide for themselves to participate or needing a LAR, or others who could be subject to coercion (subjects who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm)
• Any absolute contraindications as mentioned in the device Instruction For Use (available on ifu.stryker.com)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Gibson

Role: STUDY_DIRECTOR

Stryker Trauma and Extremities

Locations

More Foundation

Phoenix, Arizona, United States

University of Arkansas Medical Sciences

Little Rock, Arkansas, United States

Eisenhower Health Desert Orthopedic Center

Rancho Mirage, California, United States

California Pacific Orthopaedics

San Francisco, California, United States

The Center for Bone and Joint Disease

Hudson, Florida, United States

Loyola University Chicago

Maywood, Illinois, United States

Washington University

St Louis, Missouri, United States

Tennessee Orthopaedic Alliance

Columbia, Tennessee, United States

University of Texas/UT Health

Houston, Texas, United States

Countries

United States

Other Identifiers

UE-01-2022

Identifier Type: -

Identifier Source: org_study_id