Perform® Humeral System - Fracture Study (PFX)
PFX
Tornier Perform® Humeral System - Fracture Study
1 other identifier
observational
118
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 17, 2023
CompletedStudy Start
First participant enrolled
August 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2034
April 15, 2026
April 1, 2026
3.1 years
March 6, 2023
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
ASES Score = American Shoulder and Elbow Surgeons Score
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
24 Month
Secondary Outcomes (6)
Constant Score
24 Month
SANE
24 Month
EQ-5D-5L
24 Month
Patient Satisfaction
24 Month
Radiographic Findings
24 Month
- +1 more secondary outcomes
Study Arms (1)
Tornier Perform® Humeral System - Fracture
Commercially available convertible humeral system for anatomic and reverse shoulder arthroplasty.
Interventions
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.
Eligibility Criteria
Approximately 120 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an anatomic or reverse shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria.
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
More Foundation
Phoenix, Arizona, 85023, United States
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205, United States
Eisenhower Health Desert Orthopedic Center
Rancho Mirage, California, 92270, United States
California Pacific Orthopaedics
San Francisco, California, 94118, United States
The Center for Bone and Joint Disease
Hudson, Florida, 34667, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Washington University
St Louis, Missouri, 63110, United States
Tennessee Orthopaedic Alliance
Columbia, Tennessee, 38401, United States
University of Texas/UT Health
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rebecca Gibson
Stryker Trauma and Extremities
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 17, 2023
Study Start
August 31, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
September 1, 2034
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share