Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

NCT05868148 | Active Not Recruiting FDA Device

• 1 other identifier: UE-02-2021
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Massive RCT; Non-repairable RCT; Glenohumeral joint

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Performance: change in level of pain and ability to carry out normal daily activities of the patient

  from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years

• Performance: change in patient self-assessment of current status of their treated shoulder

  from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years

• Performance: change in patient self-rated quality of life

  from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years

• Performance: change in patient satisfaction with their shoulder

  from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years

• Safety: Adverse Event rate and assessments

  from date of treatment until date of study exit (study completion or early termination for any cause), assessed up to 10 years

Study Arms (1)

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.

Device: Shoulder iD™ Primary Reversed Glenoid

Interventions

Shoulder iD™ Primary Reversed Glenoid DEVICE

Device implant via reversed total shoulder arthroplasty

Also known as: Patient-Matched Primary Reversed Glenoid

Shoulder iD device implant

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (5)

UCSF

San Francisco, California, 94158, United States

Location

Jameson Crane Sports Medicine Institute OSU

Columbus, Ohio, 43202, United States

Location

UT Southwestern

Frisco, Texas, 75033, United States

Location

UT Health Science center - Houston

Houston, Texas, 77030, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Humeral Fractures; Disease

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arm Injuries; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca Gibson

  Stryker Trauma and Extremities

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 22, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2035
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)