Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCSF
RECRUITING
San Francisco
Florida
Coastal Orthopedics
WITHDRAWN
Bradenton
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Jameson Crane Sports Medicine Institute OSU
RECRUITING
Columbus
Texas
UT Southwestern
NOT_YET_RECRUITING
Frisco
UT Health Science center - Houston
RECRUITING
Houston
CHRISTUS Mother Frances Research
RECRUITING
Tyler
Virginia
Carilion Clinic
RECRUITING
Roanoke
Contact Information
Primary
Shawna Brown
shawna.brown@stryker.com
+31 6 25 02 79 41
Backup
Dana Haywood
john.haywood@stryker.com
+1 615 236 4963
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2035-12
Participants
Target number of participants: 200
Treatments
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.
Sponsors
Leads: Stryker Trauma and Extremities

This content was sourced from clinicaltrials.gov