S-33 SMR Shoulder HP Reverse Glenosphere

Arthroplasty, Replacement, Shoulder Clinical Trial

Official title:

Clinical and Radiographic Outcomes of Reverse Shoulder Arthroplasty Performed With 36-mm CoCrMo vs 40-mm Cross-linked UHMWPE Glenospheres.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339815
• Other study ID #: S-33
• Status: Recruiting
• Start date: October 17, 2022
• Est. completion date: May 2023

Study information

• Verified date: April 2022
• Source: Limacorporate S.p.a
• Contact: Ilaria Ciani
• Phone: +39 3346382670
• Email: ilaria.ciani[@]limacorporate.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Shoulder

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Wrightington, Wigan and Leigh NHS Foundation Trust	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Measure Oxford shoulder score; 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
Secondary	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.	Measure Constant Score; The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function.	From baseline to FU 24 months
Secondary	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.	Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES); American Shoulder and Elbow Surgeons (ASES) score contains a patient self-report section and a section used by medical professionals to record physical examination findings to assess patients with shoulder pathologies.; The patient self-report section of the ASES is a condition specific scale is intended to measure functional limitations and pain of the shoulder. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points.; The physician assessment section is composed by 4 parts: motion, stability, strength and physical findings.	From baseline to FU 24 months
Secondary	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.	Measure Quick DASH; The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). At least 10 of the 11 items must be completed for a score to be calculated. All items are scored on a scale of 5 (Likert) levels: 1 = no difficulty/symptoms, 2 = mild difficulty/symptoms, 3 = moderate difficulty/symptoms, 4 = severe difficulty/symptoms, and 5 = extreme difficulty (unable to do)/symptoms.; The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability.	From baseline to FU 24 months
Secondary	Survivorship of the implant (Kaplan-Meier estimate) through 2 years (24 months) of follow-up after surgery	Kaplan-Meier	From baseline to FU 24 months
Secondary	Incidence, type and severity of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effect (ADEs), Serious Adverse Device Effects (SADEs)	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