Perform® Humeral System - Fracture Study (PFX)

Running, not enrolling

Conditions studied: Traumatic Arthropathy of Shoulder, Fracture Humerus, Traumatic Arthritis, Revision of Other Devices if Sufficient Bone Stock Remains

In brief

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.

Key facts

Study ID

NCT05773352

Run by

Stryker Trauma and Extremities

People needed

118

Starts

2023-08-31

Expected to finish

2034-09-01

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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