MedTrace Logo

MDR - Comprehensive Primary Revision Stems PMCF

NCT06788717 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2026-04-28

No results posted yet for this study

Summary

The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.

Conditions

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

Interventions

DEVICE

Comprehensive Primary Revision Stems

Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Ryan Boylan, MBA · Zimmer Biomet

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2035-07-31
Completion
2040-12-31
FDA Device
Yes

Countries

  • United States
  • Denmark

Study Locations

More Related Trials

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 NCT06788717 on ClinicalTrials.gov