NCT05773352

Perform® Humeral System - Fracture Study (PFX)

Official Title:

Tornier Perform® Humeral System - Fracture 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

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)

Disease(s) and\or Condition(s)

Traumatic Arthropathy of Shoulder

Fracture Humerus

Traumatic Arthritis

Revision of Other Devices if Sufficient Bone Stock Remains

Primary Purpose
Intervention/Treatment
    • Type: DEVICE
    • Name: Tornier Perform® Humeral System - Fracture
    • Description: 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.
    • Arm Group Labels: Tornier Perform® Humeral System - Fracture
Sponsor
  • Stryker Trauma and Extremities