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NCT05868148 · ClinicalTrials.gov registry record
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
A clinical trial of Rotator Cuff Tears and Osteoarthritis Shoulder, sponsored by Stryker Trauma and Extremities.
- Active
- Registry status
- 200
- Enrollment target
- 5
- Study locations
NCT05868148 is a study of Rotator Cuff Tears and Osteoarthritis Shoulder that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 200 participants, below the 1,271-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (84% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT05868148, a study of Rotator Cuff Tears and Osteoarthritis Shoulder, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.
- ACTIVE NOT RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 5
- Study locations
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 Studied
Interventions
- DEVICE Shoulder iD™ Primary Reversed Glenoid
Study Locations (5)
Texas
- UT Southwestern - Frisco
- UT Health Science center - Houston - Houston
California
- UCSF - San Francisco
Ohio
- Jameson Crane Sports Medicine Institute OSU - Columbus
Virginia
- Carilion Clinic - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-10-20 |
| Est. Completion | 2035-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05868148
The ClinicalTrials.gov registry entry for NCT05868148 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,271-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (84% lower). The listed sponsor is Stryker Trauma and Extremities, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Rotator Cuff Tears appearing as the primary indexed condition, and to 1 intervention - of which Shoulder iD™ Primary Reversed Glenoid is the first listed.
NCT05868148 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Texas, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05868148 about?
NCT05868148 is a clinical study titled "Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study". 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 an...
What is the current status of trial NCT05868148?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2023-10-20. Estimated completion is 2035-12.
What conditions does trial NCT05868148 study?
This clinical trial studies the following conditions: Rotator Cuff Tears, Osteoarthritis Shoulder, Shoulder Deformity, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder.
What interventions are being tested in trial NCT05868148?
The interventions under investigation include: Shoulder iD™ Primary Reversed Glenoid (DEVICE).
Who is sponsoring clinical trial NCT05868148?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05868148 being conducted?
This trial has 5 study locations across California, Ohio, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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