Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
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.
|Non-inflammatory Degenerative Joint Disease (NIDJD) Avascular Necrosis Osteoarthritis Inflammatory Joint Disease (IJD) Rheumatoid Arthritis||Procedure: Shoulder Arthroplasty|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.|
- Functional Performance (Constant & Murley Score) [ Time Frame: 5 Years ]
- Survival (Kaplan-Meier) [ Time Frame: 10 years ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2024|
|Estimated Primary Completion Date:||September 2019 (Final data collection date for primary outcome measure)|
Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria.
Procedure: Shoulder Arthroplasty
Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.
This study is a prospective, noncontrolled, multi-center post market clinical follow-up study involving orthopedic surgeons skilled in hemi and total shoulder arthroplasty procedures.
A total number of 160 subjects will be included in the study.
Ethics Committee (EC) approval for each site has to be obtained prior to conducting this study. Sequentially, all eligible patients will be offered study enrollment at each center to avoid potential selection bias. All potential subjects will be required to participate in an informed consent process and sign the EC approved written Informed Consent prior to study enrollment.
The study is designed to be prospective to ensure that the study population is representative of the type of population that the device is intended to treat. Patients will be selected according to the subject selection criteria described in section 8. All subjects will undergo preoperative, intraoperative and immediate postoperative assessments including physical examinations, radiographic evaluations and collection of quality of life metrics. Follow-up evaluations are to be conducted at 3 and 6 months, 1, 2, 5, 7 and 10 years postoperation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700543
|Groupe Chirurgical Thiers|
|Centre Hospitalier Universitaire Toulouse|
|Orthopaedische Chirurgie Muenchen|
|Gemeinschaftspraxis am Wall|
|Azienda Ospedaliera Universitaria Careggi|
|Kantonsspital St Gallen|
|St Gallen, Switzerland|
|New Royal Infirmary of Edinburgh|
|Edinburgh, United Kingdom|