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

NCT05314387 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-04-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Limacorporate S.p.a

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2027-04-30
Completion
2029-04-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05314387 on ClinicalTrials.gov