Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01700543|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2012
Last Update Posted : August 2, 2017
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.
|Condition or disease||Intervention/treatment|
|Non-inflammatory Degenerative Joint Disease (NIDJD) Avascular Necrosis Osteoarthritis Inflammatory Joint Disease (IJD) Rheumatoid Arthritis||Procedure: Shoulder Arthroplasty|
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.
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2024|
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.
- Functional Performance (Constant & Murley Score) [ Time Frame: 5 Years ]
- Survival (Kaplan-Meier) [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|