SMR Stemless Shoulder Arthroplasty Clinical Study

This is an interventional treatment trial for Primary Osteoarthritis Read More

Patients meeting all the following inclusion criteria will be considered for participation in the study:

1. Both genders;
2. Age ≥ 18 years old;
3. Full skeletal maturity;
4. Life expectancy over 5 years;
5. Patient is requiring primary unilateral or bilateral anatomic or reverse arthroplasty based on physical examination and medical history;
6. Good bone quality evaluated by the Investigator on the basis of a risk factors analysis (included MORES/SCORE questionnaires) and the intraoperative evaluation;

7. A diagnosis in the target shoulder of one or more of the following:

   • Primary osteoarthritis;
   • Secondary osteoarthritis;
   • Post-traumatic arthritis;
   • Rheumatoid arthritis;
   • Avascular necrosis of the humeral head (radiologically less than 20%);
   • Cuff tear arthropathy.
8. Patient submitted to previous conservative non-surgical treatments;
9. Patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;
10. Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.

Patients will be excluded if they meet any of the following criteria:

1. Patient requiring revision shoulder arthroplasty;
2. Osteoporosis with a history of non-traumatic fractures;
3. Steroid injections within the previous 3 months;
4. Contralateral shoulder replacement within the previous 3 months;
5. Extensive avascular necrosis (radiologically more than 20%);
6. Meta-epiphyseal bony defect (including large cysts);
7. Post-traumatic tuberosity non-union;
8. Ongoing septicaemia;
9. Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
10. Significant neurological or musculoskeletal disorders that may compromise functional recovery;
11. Not recovered axillary nerve palsy;
12. Non functioning deltoid muscle;
13. Known or suspicious hypersensitivity to the metal or other components and materials of the implant;
14. Recurrent medical history of immune-mediated reactions or other systemic immune disorders;
15. Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit;
16. Previous organ transplant;
17. Any intercurrent chronic disease or condition and any significant finding that may interfere with the completion of the 60-month follow-up, such as liver disease, severe coronary disease, or other clinically significant condition that the Investigator feels may affect the study evaluation;
18. Unwillingness or inability (alcoholism, infirmity) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;
19. Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;