Status:
NOT_YET_RECRUITING
S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
Lead Sponsor:
Limacorporate S.p.a
Conditions:
Shoulder Arthritis
Shoulder Osteoarthritis
Eligibility:
All Genders
18+ years
Brief Summary
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 Ste...
Eligibility Criteria
Inclusion
- 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:
- Primary osteoarthritis;
- Secondary osteoarthritis;
- Post-traumatic arthritis;
- Rheumatoid arthritis;
- Avascular necrosis
- acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- cuff tear arthropathy (only in combination with CTA Heads);
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05314387
Start Date
April 1 2022
End Date
April 1 2029
Last Update
April 6 2022
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