S-33 SMR Shoulder HP Reverse Glenosphere

NCT05339815 | Unknown

• 1 other identifier: S-33
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (4)

• The primary endpoint is based upon achieving composite clinical success (CCS)

  The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: \- No continuous radiolucent line around the implant Glenoid Component Radiolucency will be graded in accordance with the following definitions: 0\. Absent: No evidence of radiolucency \> 2 mm in width along the bone-implant interface in any zone. 1\. Present: Presence of radiolucency \> 2 mm in width along the bone-implant interface in one or more zones

  From baseline to FU 24 months

• The primary endpoint is based upon achieving composite clinical success (CCS)

  The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: \- Change from baseline of the Oxford Should Score ≥ 6 points. Oxford Shoulder Score (OSS) is a 12-item patient-reported PRO specifically designed and developed for assessing outcomes of shoulder surgery.

  From baseline to FU 24 months

• The primary endpoint is based upon achieving composite clinical success (CCS)

  The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: \- No revision or removals. A removal of the glenosphere component is intended as a revision and of the implant.

  From baseline to FU 24 months

• The primary endpoint is based upon achieving composite clinical success (CCS)

  The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: No system-related SAE (device-related) Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points.

  From baseline to FU 24 months

Secondary Outcomes (6)

• Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.

  From baseline to FU 24 months

• Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.

  From baseline to FU 24 months

• Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.

  From baseline to FU 24 months

• Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.

  From baseline to FU 24 months

• Survivorship of the implant (Kaplan-Meier estimate) through 2 years (24 months) of follow-up after surgery

  From baseline to FU 24 months

Study Arms (2)

36 mm CoCrMo glenospheres

Device: SMR shoulder arthroplasty

40 mm cross-linked UHMWPE glenospheres

Device: SMR shoulder arthroplasty

Interventions

SMR shoulder arthroplasty DEVICE

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

36 mm CoCrMo glenospheres; 40 mm cross-linked UHMWPE glenospheres

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, United Kingdom

RECRUITING

Central Study Contacts

Ilaria Ciani

CONTACT

+39 3346382670; ilaria.ciani@limacorporate.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 21, 2022
• Study Start: October 17, 2022
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 24, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)