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Sidus(TM) Post Market Clinical Follow-up (PMCF) Study

NCT01700543 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2025-11-25

No results posted yet for this study

Summary

This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.

The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events.

The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant \& Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder.

The Sidus Stem-Free Shoulder is not approved for use in the US.

Conditions

Interventions

PROCEDURE

Shoulder Arthroplasty

Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.

Sponsors & Collaborators

  • Zimmer, GmbH

    collaborator INDUSTRY

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Emilie Rohmer · Zimmer Biomet

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2020-07-31
Completion
2026-03-31

Countries

  • Austria
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01700543 on ClinicalTrials.gov