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PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System

Recruitingn/aAges 18 Years - anyAllZimmer Biomet
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In plain words

What the trial is, and whether it could suit you

The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder Bipolar System (Implants and Instrumentation) when used as a salvage solution in shoulder replacement. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Helios ENDO-Klinik
Hamburg, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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