Status:
UNKNOWN
S-33 SMR Shoulder HP Reverse Glenosphere
Lead Sponsor:
Limacorporate S.p.a
Conditions:
Arthroplasty, Replacement, Shoulder
Eligibility:
All Genders
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 as per Instruction for Use
- Patient was an adult male or female and was 18 years of age or older at the time of surgery
- Patient received the SMR Reverse Shoulder System for primary, fracture, or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthroplasty
- The patient's joint was anatomically and structurally suited to receive the selected implants, with a functional deltoid muscle
- Surgery date is at least 24 months from screening of data
- Patient has baseline radiographs and Oxford Shoulder Score
Exclusion
- 1 Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 out of the Indications for Use
Key Trial Info
Start Date :
October 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05339815
Start Date
October 17 2022
End Date
May 1 2023
Last Update
October 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, United Kingdom