SMR Stemless Shoulder Arthroplasty Clinical Study

A regiszterben nem jelölt feltételek

• Patients meeting all the following inclusion criteria will be considered for participation in the study:
• Both genders;
• Age ≥ 18 years old;
• Full skeletal maturity;
• Life expectancy over 5 years;
• Patient is requiring primary unilateral or bilateral anatomic or reverse arthroplasty based on physical examination and medical history;
• Good bone quality evaluated by the Investigator on the basis of a risk factors analysis (included MORES/SCORE questionnaires) and the intraoperative evaluation;
• 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.
• Patient submitted to previous conservative non-surgical treatments;
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;
• 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:
• Patient requiring revision shoulder arthroplasty;
• Osteoporosis with a history of non-traumatic fractures;
• Steroid injections within the previous 3 months;
• Contralateral shoulder replacement within the previous 3 months;
• Extensive avascular necrosis (radiologically more than 20%);
• Meta-epiphyseal bony defect (including large cysts);
• Post-traumatic tuberosity non-union;
• Ongoing septicaemia;
• Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
• Significant neurological or musculoskeletal disorders that may compromise functional recovery;
• Not recovered axillary nerve palsy;
• Non functioning deltoid muscle;
• Known or suspicious hypersensitivity to the metal or other components and materials of the implant;
• Recurrent medical history of immune-mediated reactions or other systemic immune disorders;
• Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit;
• Previous organ transplant;
• 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;
• 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;
• Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;