S-33 SMR Shoulder HP Reverse Glenosphere
NCT05339815 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 140
Last updated 2022-10-24
Summary
Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision total shoulder replacement out to 24 months. The eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres between January 1, 2013 and January 1, 2020 at Wrightington Hospital (UK) in accordance with the indication for use of the product.
Conditions
- Arthroplasty, Replacement, Shoulder
Interventions
- DEVICE
-
SMR shoulder arthroplasty
Data collection of population that underwent a reverse shoulder arthroplasty performed with SMR 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres
Sponsors & Collaborators
-
Limacorporate S.p.a
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-17
- Primary Completion
- 2023-02-28
- Completion
- 2023-05-31
Countries
- United Kingdom
Study Locations
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