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NCT04003311

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Enrolling by Invitation
Not specifiedAges 18+Observational
Zimmer Biomet
~146 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Comprehensive Primary Micro StemComprehensive Anatomic Versa-Dial Titanium Humeral Head

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events
Measured over Out to 10 years

Conditions

Shoulder Pain
Shoulder Injuries
Shoulder Fractures
Shoulder Disease
Shoulder Arthritis

Explore related trials

Avascular NecrosisInjury of shoulder regionOsteoarthritisRheumatoid ArthritisShoulder FractureShoulder Pain

NCT04003311

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beaumont Health

    Royal Oak, Michiganno site contact published

  • Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont

    Burlington, Vermontno site contact published

  • Shoulder Clinic of Idaho

    Boise, Idahono site contact published

  • University of Rochester

    Rochester, 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

Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads
Patient must be 18 years of age or older.
Patient must have undergone a primary or revision shoulder arthroplasty with the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads for a cleared indication. Cleared indications include the following:
non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
rheumatoid arthritis,
revision where other devices or treatments have failed,
correction of functional deformity,
fractures of the proximal humerus where other methods of treatment are deemed inadequate,
difficult clinical management problems including cuff arthroplasty where other treatment methods may not be suitable or may be inadequate.

Exclusion

Absolute contraindications include infection, sepsis, and osteomyelitis.
Relative contraindications include:
Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
Osteoporosis
Metabolic disorders which may impair bone formation
Osteomalacia
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Patient is a prisoner.
Patient is a current alcohol or drug abuser.
Patient is known to be pregnant or breastfeeding.
Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.

What this trial measures

  • Device Safety assessed through the frequency and incidence of revisions, complications and Adverse EventsOut to 10 years

    The primary objective of this study 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.