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

First listed
Jul 1, 2019
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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