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

NCT04003311 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 146

Last updated 2025-10-30

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Comprehensive Anatomic Versa-Dial Titanium Humeral Head

Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.

DEVICE

Comprehensive Primary Micro Stem

Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Erin Osborn · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2028-07-29
Completion
2028-07-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04003311 on ClinicalTrials.gov