Perform® Humeral System - Fracture Study (PFX) (NCT05773352) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Perform® Humeral System - Fracture Study (PFX)
United States118 participantsStarted 2023-08-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
ASES Score = American Shoulder and Elbow Surgeons Score