🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT05358574
Recruiting Observational

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

NCT05358574 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2022-04-22
Last updated
2025-11-25

Condition(s) studied

Revision of a Shoulder Prosthesis

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Helios ENDO-Klinik Hamburg Germany Recruiting

More Zimmer Biomet trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05358574 on ClinicalTrials.gov ↗ ← All trials in Germany