NCT05314387 - S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem | Crick

Interventions

SMR TT Hybrid Glenoid without Cementless Finned Short StemDEVICE

SMR TT Hybrid Glenoid with Cementless Finned Short StemDEVICE

The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation. The fins are intended to enhance press-fit fixation. The same proximal morse taper is used for coupling to the same humeral bodies in the SMR Shoulder System. The SMR finned short stem is intended for cementless fixation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of patients reaching a clinical progression from baseline to 24-month follow-up

The primary endpoint consists of the proportion of patients reaching a clinical progression from baseline to 24-month follow-up measured as: * Constant score improvement of greater than 10; * Adjusted Constant score greater than or equal to 54.

Time frame: 24 Months

Secondary Outcomes

Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES)

The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.