Evaluating the Safety and Performance of a Shoulder Replacement System
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ Bipolar System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
This study is trying to see how safe and effective a new shoulder replacement system is for patients who had the surgery between 2009 and 2020.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT05358574 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect long-term data on the safety and clinical benefits of the Anatomical Shoulder Bipolar System used in shoulder replacements. It will analyze implant survivorship by tracking revisions, complications, and adverse events, while also assessing performance through patient-reported outcomes and radiographic evaluations. The study will include a maximum of 40 patients who received the implant from 2009 to 2020, with follow-up assessments conducted at various intervals post-surgery. Data will be collected retrospectively and prospectively to ensure comprehensive evaluation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-100 who have received the Anatomical Shoulder Bipolar System as a salvage solution for shoulder replacement.
Not a fit: Patients who are unable or unwilling to comply with follow-up visits or have conditions that pose undue risk 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 Bipolar System for patients requiring shoulder revision surgery.
How similar studies have performed: While similar studies on shoulder prosthesis safety and performance exist, this specific approach to evaluating the Anatomical Shoulder Bipolar System is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The Anatomical Should Bipolar Adaptor is indicated for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible 2. Patient should have received the Anatomical Shoulder Bipolar System 3. Patient should have signed the Informed Consent Form 4. Patient is 18-100 years of age, inclusive 5. Patient is skeletally mature Exclusion Criteria: 1. Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule 2. Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them 3. Patient is known to be pregnant or breastfeeding 4. Musculoskeletal situation that enables the application of a regular hemi or total shoulder system 5. Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is possible 6. Patient's physical conditions that would impair achieving adequate implant support, and/or prevent the use of an appropriately sized implant (e.g. due to insufficient quality or quantity of bone). 7. Signs of infection 8. Non-functional deltoid muscle 9. Charcot's shoulder (neuroarthropathy) 10. Presence of significant injury to the upper brachial plexus 11. Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention
Where this trial is running
Hamburg
- Helios ENDO-Klinik — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Julie Nicoux
- Email: julie.nicoux@zimmerbiomet.com
- Phone: +330672613502
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.