Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study — SiD  

Rotator Cuff Tears Clinical Trial

Official title: Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Status Recruiting

Clinical Trial Summary

The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are:

• What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and

• What is the rate of surgical revisions needed over a 10 year period

Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes.

Clinical Trial Description

The Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is a Global, single arm, multicenter, prospective, non-significant risk Post-Market Clinical Follow-up (PMCF) study, designed to collect safety and performance data on designated commercially available Shoulder iD™ Primary Reversed Glenoid.

The objective of this multicenter study is to collect clinical data at baseline, surgery, immediate post-op, and annually through 10 years post-operation, on related clinical complications and clinical outcomes of market-approved Shoulder iD™ Primary Reversed Glenoid, to demonstrate safety and performance of these implants in a real-world setting.

The primary outcome measure is the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months.

Secondary outcome measures include the following assessments to be evaluated throughout the patient's participation in the study:

• Constant Score (years 1, 2, 5 and 10 only)

• Single Assessment Numeric Evaluation (SANE) Score

• Patient Satisfaction

• EQ-5D-5L

Radiologic imaging: Patient images (X-ray or CT) completed at baseline and in-person follow-ups will be analyzed for standard radiographic findings, including, but not limited to: device migration, component breakage, radiolucencies and bone characteristics.

Revision rate and survivorship will be assessed annually and at any time upon request for regulatory purposes such as PMCF or Clinical Evaluation Report (CER) updates. The cumulative incidence of device revisions and reoperations will be reported as well as Kaplan-Meier estimates for implant survival.

Adverse events will be evaluated from inclusion to last follow-up and will be documented during the study and categorized as whether they are serious and whether they are related to the Sponsor device or implant procedure.

During the study, patients will undergo the following procedures, which are standard of care:

• Patient information and Consent (as applicable per local regulation),

• Inclusion/non-inclusion criteria,

• Demography, Height & Weight,

• Surgical history and relevant medical history,

• Physician exams (Range of Motion and Strength measurements),

• Patient questionnaires (ASES, Constant, SANE, Patient Satisfaction, EQ-5D-5L),

• Shoulder study implant & surgery related data,

• CT scans, x-rays

• AE / SAE collection (continuous recording). ;

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis of the Head of Humerus
• Humeral Fractures
• Necrosis
• Osteoarthritis Shoulder
• Rheumatoid Arthritis Shoulder
• Rotator Cuff Injuries
• Rotator Cuff Tears

• NCT number: NCT05868148
• Study type: Observational
• Source: Stryker Trauma GmbH
• Contact: Shawna Brown
• Phone: +31 6 25 02 79 41
• Email: shawna.brown@stryker.com
• Status: Recruiting
• Start date: October 20, 2023
• Completion date: December 2035