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MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

NCT04003272 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2026-02-06

No results posted yet for this study

Summary

The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up\* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data.

\*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.

Conditions

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

Interventions

DEVICE

Comprehensive Reverse Versa-Dial Titanium Glenosphere

Implant used for patients with allergy to typical device material metals 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
2019-10-28
Primary Completion
2034-08-19
Completion
2035-09-01
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 NCT04003272 on ClinicalTrials.gov