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ACTIVE NOT RECRUITING
NCT01700543

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

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

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.

Official title: Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

152

Start Date

2012-10

Completion Date

2026-03

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

PROCEDURE

Shoulder Arthroplasty

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

Locations (8)

AKH Linz

Linz, Austria

Groupe Chirurgical Thiers

Grenoble, France

Centre Hospitalier Universitaire Toulouse

Toulouse, France

Charité

Berlin, Germany

Orthopaedische Chirurgie Muenchen

Munich, Germany

Gemeinschaftspraxis am Wall

Rinteln, Germany

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

New Royal Infirmary of Edinburgh

Edinburgh, United Kingdom