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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A03228-49 | Registry Identifier | ID-RCB |
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The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy.
The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.
This study is a prospective, national, multicenter, non-controlled, non-randomized study in order to evaluate outcomes of the MSS reverse prosthesis used for the management of primary osteoarthritis, cuff tear arthropathy, massive cuff tear, or post-instability arthroplasty.
Included patients, will have an oral and written information about the study, including the information note, during a preoperative visit. The surgeon will answer any questions that may arise and will collect their decision after sufficient time for the patient to reflect.
Patients participating in the research will be able to withdraw their consent and ask to stop the study at any time and for any reason. The investigator should document the reasons as fully as possible.
Patients will be followed according to the schedule below:
The surgical technique for implantation of the Reverse Medacta Shoulder System total shoulder prosthesis will be performed according to the MyShoulder pre-operative planning (without custom-made guides). All procedures will be performed with conventional instrumentation according to each surgeon's current practice. It is possible to use the BIO-RSA technique to reposition the pre-morbid glenoid center. The stem that will be used is the short stem (cementless) with PE angulation at 145°.
The following data will be collected at each of the 3 month, 1 year and 2 year :
A web-based data collection medium will be used for this study. All the information required by the protocol will be collected in a e-crf. It requires only an Internet connection and a browser. A help document for the use of this tool will be provided to the investigators.
Data management for the study will be handled by a CIC INSERM 1415 data-manager. The electronic case report form (eCRF) will be developed using Ennov Clinical® software. Data management will be done according to the standard operating procedures (edited in CIC INSERM 1415. The Clinical Research Assistant in charge of the study will be trained in the use of the eCRF, then will be in charge of the training of investigators. Data relating to post-operative radiological data will be entered on the eCRF directly by the independent assessors commissioned for the centralized review of radiological examinations.
Analyses will be performed with SAS Version 9.4 (or later). The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.
A statistical analysis report will be written integrating all the elements to be reported.
A clinical research assistant will ensure the rigourous conduct of the study, the collection of the data generated in writing, their documentation, recording and reporting, in accordance with the Promotion and Quality Control Unit of the Tours CHRU as well as the legal and regulatory provisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shoulder prothesis | Experimental | Evaluate the performance of the Medacta Shoulder System total reverse shoulder prothesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medacta Shoulder System | Device | Surgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder function by evaluation of Constant's Score | The main evaluation criteria is the rate of improvement of the Constant Score and preoperative and postoperative mobility (active external and internal rotation, elbow to body) at 2 years post surgery. | 2 years post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Assess the complication rate associated with the MSS prosthesis (safety of the prosthesis, safety of the prosthesis, etc.). | At 2 years post surgery |
| Survival implants | Evaluate the survival of Reverse Medacta Shoulder System implants |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | France | ||||
| Chu Rennes |
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| At 2 years post surgery |
| Position of the prosthesis | Evaluate the positioning of the prosthesis by radiological analysis | At 3 months, 1 year and 2 years post-surgery. |
| Bone behaviour | Evaluation of bone behaviour in contact with the humeral stem | At 3 months, 1 year and 2 years post-surgery. |
| Subjective Shoulder Value | Assess patient satisfaction after surgery at 3 months, 1 year and 2 years post-surgery | At 3 months, 1 year and 2 years post-surgery |
| Oxford Shoulder Score | Assess patient satisfaction after surgery at 3 months, 1 year and 2 years post-surgery | At 3 months, 1 year and 2 years post-surgery |
| Shoulder function by evaluation of Constant's Score | Evaluate the evolution of shoulder function in patients who received a Medacta Shoulder System reverse ETP with MyShoulder preoperative planning (without custom guides). | At 3 months and 1 year post-surgery |
| Rennes |
| France |
| Clinique Mutualiste la Sagesse | Rennes | France |
| Polyclinique santé atlantique | Saint-Herblain | France |
| Chu Tours | Tours | France |