Evaluating the Safety and Performance of a Shoulder Replacement System

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Helios ENDO-Klinik
  Hamburg, Germany Recruiting

Study contacts

• Study coordinator: Julie Nicoux
• Email: julie.nicoux@zimmerbiomet.com
• Phone: +330672613502

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating the Zimmer Biomet Shoulder Replacement System

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• Evaluating Hi-Fatigue G Bone Cement in Hip and Knee Replacements

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  Recruiting Zimmer Biomet · Weiden, Bavaria · NCT06699134

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.