NCT05314387

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Limacorporate S.p.a · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Stem

Conditions

• Shoulder Arthritis
• Shoulder Osteoarthritis
• Arthrosis
• Osteoarthritis
• Rheumatoid Arthritis
• Arthroplasty
• Avascular Necrosis
• Humeral Fractures
• Cuff Tear Arthropathy

Interventions

Type	Name	Description
DEVICE	SMR TT Hybrid Glenoid without Cementless Finned Short Stem	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.
DEVICE	SMR TT Hybrid Glenoid with Cementless Finned Short Stem	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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2027-04-01
• Completion: 2029-04-01
• First posted: 2022-04-06
• Last updated: 2022-04-06

Regulatory

• FDA-regulated device study