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

Launched by LIMACORPORATE S.P.A · Mar 29, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of shoulder surgery called shoulder arthroplasty, which involves replacing parts of the shoulder joint. Specifically, the study will analyze the outcomes of using a special implant called the SMR TT Hybrid Glenoid, with or without another implant called the Cementless Finned Short Stem. The goal is to see how well these implants work for patients suffering from various shoulder conditions, such as arthritis or fractures.

To participate in this trial, patients need to be at least 18 years old and have a specific shoulder condition that requires surgery, like osteoarthritis or rheumatoid arthritis. They should also be in good overall health, with good bone quality. However, certain individuals, such as those with severe infections or certain neurological disorders, cannot join. Participants can expect to undergo a surgical procedure and will be monitored afterward to evaluate how well the new implants are working over time. This study is not yet recruiting participants, but it aims to help improve shoulder surgeries for many patients in the future.

Gender

ALL

Eligibility criteria

• • 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.