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Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
Sponsor: Zimmer Biomet
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
Conditions
Interventions
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