Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study (SiD)

• ClinicalTrials.gov Identifier: NCT05868148
• Recruitment Status: Recruiting
• First Posted: May 22, 2023
• Last Update Posted: April 17, 2024
• Sponsor: Stryker Trauma GmbH
• Information provided by (Responsible Party): Stryker Trauma GmbH

Tracking Information

• First Submitted Date: April 21, 2023
• First Posted Date: May 22, 2023
• Last Update Posted Date: April 17, 2024
• Actual Study Start Date: October 20, 2023
• Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2023)

• Performance: change in functional ability of the treated shoulder [ Time Frame: from baseline to 24 months ]
  The average change in functional ability as measured by the American Shoulder and Elbow Surgeons (ASES) score. ASES is an absolute score ranging from 0 to 100 where a higher score indicates better shoulder function.
• Safety: Revision rate and device survivorship [ Time Frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years ]
  The cumulative incidence of device revisions and reoperations

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 11, 2023)

• Performance: change in level of pain and ability to carry out normal daily activities of the patient [ Time Frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years ]
  Assessed via the Constant-Murley Shoulder score collected at baseline, years 1, 2, 5 and 10 and any other standard collection timepoint. In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of rage of movement and shoulder strength. A score of 100 is a healthy shoulder.
• Performance: change in patient self-assessment of current status of their treated shoulder [ Time Frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years ]
  Assessed via the Single Assessment Numeric Evaluation (SANE) score collected from patients via ePRO at baseline, 3 months, and annually. The rating is from 0% to 100% with 100% being normal.
• Performance: change in patient self-rated quality of life [ Time Frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years ]
  Assessed via EQ-5D-5L Five Dimensions Quality of Life measurement general health questionnaire collected from patients via ePRO at baseline, 3 months and annually. Each dimension is measured on 5 levels from 1 being no problems to 5 being extreme problems.
• Performance: change in patient satisfaction with their shoulder [ Time Frame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years ]
  Satisfaction rating collected from patients via ePRO at baseline, 3 months and annually. Rating options are: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied.
• Safety: Adverse Event rate and assessments [ Time Frame: from date of treatment until date of study exit (study completion or early termination for any cause), assessed up to 10 years ]
  Cumulative incidence of procedure and/or device related events (ADE, AESI, SAE, SADE)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
• Official Title: Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Brief 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.

Detailed 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).

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample

Study Population

The intended patient population are adult patients who have reached skeletal maturity, with a functional deltoid muscle, and massive and non-repairable rotator cuff tear within one or more indications and zero contraindications with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of glenohumeral joint if sufficient native glenoid bone remains

Condition

• Rotator Cuff Tears
• Rheumatoid Arthritis Shoulder
• Osteoarthritis Shoulder
• Avascular Necrosis of the Head of Humerus
• Fracture, Humeral
• Traumatic Arthritis of Right Shoulder Region (Diagnosis)
• Shoulder Deformity

Intervention

Device: Shoulder iD™ Primary Reversed Glenoid

Device implant via reversed total shoulder arthroplasty

Other Name: Patient-Matched Primary Reversed Glenoid

Study Groups/Cohorts

Shoulder iD device implant

Adult patients who have reached skeletal maturity, with a functional deltoid muscle, and massive and non-repairable rotator cuff tear within one or more indications and zero contraindications who will receive the Shoulder iD Primary Reversed Glenoid device to replace the shoulder joint.

Intervention: Device: Shoulder iD™ Primary Reversed Glenoid

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 11, 2023): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2035
• Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 years or older at the time of the informed consent or non-opposition (when applicable).
• Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
• Willing and able to comply with the requirements of the study protocol.
• Considered a candidate for shoulder arthroplasty using a study device.
• Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

Exclusion Criteria:

• Patients who are not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times).
• Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred to as a "vulnerable subject" in section 3.44 of the ISO 14155:2020).
• Active local or systemic infection, sepsis, or osteomyelitis
• Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery)
• Significant injury to the brachial plexus
• Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the device components
• Neuromuscular disease (e.g., joint neuropathy) Known allergy to one of the product materials
• Metabolic disorders which may impair bone formation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Shawna Brown; +31 6 25 02 79 41; shawna.brown@stryker.com

Contact: Dana Haywood; +1 615 236 4963; john.haywood@stryker.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05868148
• Other Study ID Numbers: UE-02-2021
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stryker Trauma GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Stryker Trauma GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Rebecca Gibson; Stryker Trauma and Extremities

• PRS Account: Stryker Trauma GmbH
• Verification Date: April 2024