Traumatic Arthropathy of ShoulderFracture HumerusTraumatic ArthritisRevision of Other Devices if Sufficient Bone Stock Remains
Investigational drug(s) / intervention(s)
Tornier Perform® Humeral System - Fracture
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
ASES Score = American Shoulder and Elbow Surgeons Score — 24 Month 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
Trial sites (9)
Facility
City
Region
Status
More Foundation
Phoenix
Arizona
University of Arkansas Medical Sciences
Little Rock
Arkansas
Eisenhower Health Desert Orthopedic Center
Rancho Mirage
California
California Pacific Orthopaedics
San Francisco
California
The Center for Bone and Joint Disease
Hudson
Florida
Loyola University Chicago
Maywood
Illinois
Washington University
St Louis
Missouri
Tennessee Orthopaedic Alliance
Columbia
Tennessee
University of Texas/UT Health
Houston
Texas
More Stryker Trauma and Extremities trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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