Evaluating the Anatomical Shoulder 2.0 Fracture System for shoulder surgeries
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ 2.0 Fracture System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
This study is testing how well the Anatomical Shoulder 2.0 Fracture System works for shoulder surgeries by looking at patient outcomes and any complications over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 1 site (Salamanca) |
| Trial ID | NCT05351112 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone shoulder arthroplasty for complex fractures or posttraumatic conditions.
Not a fit: Patients with contraindications to shoulder arthroplasty or those unable to comply with follow-up requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the Anatomical Shoulder 2.0 Fracture System, potentially improving patient outcomes in shoulder surgeries.
How similar studies have performed: Other studies on shoulder arthroplasty devices have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Salamanca
- Salamenca University Hospital — Salamanca, Spain (Recruiting)
Study contacts
- Study coordinator: Julie Nicoux
- Email: julie.nicoux@zimmerbiomet.com
- Phone: +33 06 72 61 35 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.