Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Rotator Cuff Tears Clinical Trial

— SiD  

Official title:

Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868148
• Other study ID #: UE-02-2021
• Status: Recruiting
• Start date: October 20, 2023
• Est. completion date: December 2035

Study information

• Verified date: April 2024
• Source: Stryker Trauma GmbH
• Contact: Shawna Brown
• Phone: +31 6 25 02 79 41
• Email: shawna.brown[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2035
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Device:
• Shoulder iD™ Primary Reversed Glenoid
Device implant via reversed total shoulder arthroplasty

Locations

Country	Name	City	State
United States	Coastal Orthopedics	Bradenton	Florida
United States	Jameson Crane Sports Medicine Institute OSU	Columbus	Ohio
United States	UT Health Science center - Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance: change in functional ability of the treated shoulder	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.	from baseline to 24 months
Primary	Safety: Revision rate and device survivorship	The cumulative incidence of device revisions and reoperations	from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Secondary	Performance: change in level of pain and ability to carry out normal daily activities of the patient	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.	from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Secondary	Performance: change in patient self-assessment of current status of their treated shoulder	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.	from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Secondary	Performance: change in patient self-rated quality of life	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.	from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Secondary	Performance: change in patient satisfaction with their shoulder	Satisfaction rating collected from patients via ePRO at baseline, 3 months and annually. Rating options are: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied.	from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Secondary	Safety: Adverse Event rate and assessments	Cumulative incidence of procedure and/or device related events (ADE, AESI, SAE, SADE)	from date of treatment until date of study exit (study completion or early termination for any cause), assessed up to 10 years