NCT04003272
MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere
Enrolling by Invitation
Not specifiedAges 18+ObservationalZimmer Biomet
~59 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Comprehensive Reverse Versa-Dial Titanium Glenosphere
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Product Safety assessed through the incidence and frequency of revisions, complications and adverse events
Measured over Out to 10 years
Conditions
Where it's being run
2 sites across 2 statesKentucky1
New York1
Study leadership
- Erin Osborn · STUDY_DIRECTOR · Zimmer Biomet
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
Exclusion
Absolute contraindications include infection, sepsis, and osteomyelitis.
What this trial measures
- Product Safety assessed through the incidence and frequency of revisions, complications and adverse eventsOut to 10 years
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 either implant or instrumentation should be specified.