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NCT04003272

MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Enrolling by Invitation
Not specifiedAges 18+Observational
Zimmer 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

Shoulder Pain
Shoulder Injuries
Shoulder Fractures
Shoulder Arthritis
Shoulder Disease

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NCT04003272

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Norton Orthopaedic and Sports Medicine

    Louisville, Kentuckyno site contact published

  • University of Buffalo

    Buffalo, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Erin Osborn · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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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.