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

Part of paid clinical trials in Boise, Idaho.

Sponsor
Zimmer Biomet
Study ID
NCT04003311
Status
Enrolling By Invitation

Conditions

  • Shoulder Arthritis
  • Shoulder Disease
  • Shoulder Fractures
  • Shoulder Injuries
  • Shoulder Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Comprehensive Primary Micro Stem — DEVICE
    Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
  • Comprehensive Anatomic Versa-Dial Titanium Humeral Head — DEVICE
    Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.

Study Details

The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.

Key Dates

Start date
Dec 13, 2019
Status verified
Oct 2025
Primary completion
Jul 29, 2028
Completion
Jul 29, 2028

Study Design

Enrollment
146 participants (estimated)

Arms

  • Arm: Comprehensive Primary Micro Stem
    Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
  • Arm: Comprehensive Anatomic Versa-Dial Titanium Humeral Heads
    Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads to repair shoulder malfunction/disease.

Primary Outcome Measure

Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events [ Time Frame: Out to 10 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Shoulder Clinic of IdahoBoiseIdaho83704-
Beaumont HealthRoyal OakMichigan48073-
University of RochesterRochesterNew York14642-
Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of VermontBurlingtonVermont05405-

Find similar trials in Boise, ID

By research site
Shoulder Clinic of Idaho· Boise, IDBeaumont Health· Royal Oak, MIUniversity of Rochester· Rochester, NYDepartment of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont· Burlington, VT

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