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

Limacorporate

Status

Not yet enrolling

Conditions

Shoulder Osteoarthritis

Humeral Fractures

Osteoarthritis

Arthroplasty

Shoulder Arthritis

Cuff Tear Arthropathy

Avascular Necrosis

Arthrosis

Rheumatoid Arthritis

Treatments

Device: SMR TT Hybrid Glenoid with Cementless Finned Short Stem

Device: SMR TT Hybrid Glenoid without Cementless Finned Short Stem

Study type

Observational

Funder types

Industry

Identifiers

NCT05314387

S-11

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.