S-33 SMR Shoulder HP Reverse Glenosphere

NCT ID: NCT05339815

Last Updated: 2022-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-17

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Shoulder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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36 mm CoCrMo glenospheres

SMR shoulder arthroplasty

Intervention Type DEVICE

Data collection of population that underwent a reverse shoulder arthroplasty performed with SMR 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres

40 mm cross-linked UHMWPE glenospheres

SMR shoulder arthroplasty

Intervention Type DEVICE

Data collection of population that underwent a reverse shoulder arthroplasty performed with SMR 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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 as per Instruction for Use
2. Patient was an adult male or female and was 18 years of age or older at the time of surgery
3. 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
4. The patient's joint was anatomically and structurally suited to receive the selected implants, with a functional deltoid muscle
5. Surgery date is at least 24 months from screening of data
6. Patient has baseline radiographs and Oxford Shoulder Score

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Limacorporate S.p.a

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Ilaria Ciani

Role: CONTACT

+39 3346382670

Facility Contacts

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Ilaria Ciani

Role: primary

Other Identifiers

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S-33

Identifier Type: -

Identifier Source: org_study_id

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