Actively Recruiting
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
Led by Zimmer Biomet · Updated on 2025-11-25
40
Participants Needed
1
Research Sites
586 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The Anatomical Shoulder Bipolar Adaptor is intended for hemi shoulder replacement when a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was planned but glenoid fixation attachment is not possible
- Patient must have received the Anatomical Shoulder Bipolar System
- Patient must have signed the Informed Consent Form
- Patient must be aged between 18 and 100 years, inclusive
- Patient must be skeletally mature
You will not qualify if you...
- Patients unwilling to return for required follow-up visits or comply with the follow-up schedule
- Patients with any condition that increases risk or interferes with the study, including institutionalization, drug abuse, alcoholism, or inability to understand study requirements
- Patients who are pregnant or breastfeeding
- Musculoskeletal conditions allowing use of a regular hemi or total shoulder system
- Adequate glenoid bone quality or quantity allowing Zimmer Anatomical Shoulder Inverse/Reverse fixation
- Physical conditions preventing adequate implant support or proper implant sizing
- Signs of infection
- Non-functional deltoid muscle
- Charcot's shoulder (neuroarthropathy)
- Significant injury to the upper brachial plexus
- Neuromuscular or vascular disease affecting the limb that could endanger intervention success
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Helios ENDO-Klinik
Hamburg, Germany, 22767
Actively Recruiting
Research Team
J
Julie Nicoux
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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