Status:
RECRUITING
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
Lead Sponsor:
Zimmer Biomet
Conditions:
Revision of a Shoulder Prosthesis
Eligibility:
All Genders
18+ years
Brief Summary
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 sa...
Detailed Description
The Anatomical Shoulder Bipolar System is intended for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally plann...
Eligibility Criteria
Inclusion
- 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
- Patient should have received the Anatomical Shoulder Bipolar System
- Patient should have signed the Informed Consent Form
- Patient is 18-100 years of age, inclusive
- Patient is skeletally mature
Exclusion
- 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
- 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
- Patient is known to be pregnant or breastfeeding
- Musculoskeletal situation that enables the application of a regular hemi or total shoulder system
- Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is possible
- 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).
- Signs of infection
- Non-functional deltoid muscle
- Charcot's shoulder (neuroarthropathy)
- Presence of significant injury to the upper brachial plexus
- Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention
Key Trial Info
Start Date :
April 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 16 2033
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05358574
Start Date
April 22 2022
End Date
July 16 2033
Last Update
November 25 2025
Active Locations (1)
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1
Helios ENDO-Klinik
Hamburg, Germany, 22767