S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem

A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem

Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem

Inclusion Criteria:(Key)

• Both genders;

• Age ≥ 18 years old;

• Full skeletal maturity;

• Life expectancy over 5 years;

• Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;

• Good bone quality evaluated by the Investigator and the intraoperative evaluation;

• A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:

  1. Primary osteoarthritis;
  2. Secondary osteoarthritis;
  3. Post-traumatic arthritis;
  4. Rheumatoid arthritis;
  5. Avascular necrosis
  6. acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
  7. cuff tear arthropathy (only in combination with CTA Heads);
  8. Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.

Exclusion Criteria (Key):

• 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;
• 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;
• Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;
• Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.

These are key eligibility criteria, other eligibility criteria apply.