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Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

NCT05868148 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-01-08

No results posted yet for this study

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

  • 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

Interventions

DEVICE

Shoulder iD™ Primary Reversed Glenoid

Device implant via reversed total shoulder arthroplasty

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma and Extremities

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2027-12-31
Completion
2035-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868148 on ClinicalTrials.gov