Evaluating the Anatomical Shoulder 2.0 Fracture System for shoulder surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect long-term data on the safety, performance, and clinical benefits of the Anatomical Shoulder 2.0 Fracture System used in shoulder arthroplasty. It involves a multicenter approach, gathering both retrospective and prospective data from patients who have undergone surgery since 2014. The primary focus is on assessing implant survivorship through the incidence of revisions and complications, while secondary objectives include evaluating patient-reported outcomes and radiographic results during follow-up visits over a decade. The study will include a total of 78 cases from two sites, with comprehensive data collection at various postoperative intervals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients 18 years or older and skeletally mature
* Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study
* Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:

  1. Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment
  2. Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
  3. Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment
  4. Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus
  5. Posttraumatic necrosis of the humeral head
  6. Posttraumatic arthrosis after humeral head fracture

Exclusion Criteria:

* Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and/or to comply with the follow-up program.
* The patient is known to be pregnant or breastfeeding
* Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
* Patients with plans to relocate during the study follow-up period
* Signs of infection
* Extensive stiffening of the shoulder joint without pain

Where it's running

• Salamenca University Hospital
  Salamanca, Spain Recruiting

Study contacts

• Study coordinator: Julie Nicoux
• Email: julie.nicoux@zimmerbiomet.com
• Phone: +33 06 72 61 35 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.