Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Condition
Rotator Cuff Tears
Intervention / Treatment

-

Contacts and Locations

San Francisco

UCSF, San Francisco, California, United States, 94158

Bradenton

Coastal Orthopedics, Bradenton, Florida, United States, 34212

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Columbus

Jameson Crane Sports Medicine Institute OSU, Columbus, Ohio, United States, 43202

Houston

UT Health Science center - Houston, Houston, Texas, United States, 77030

Tyler

CHRISTUS Mother Frances Research, Tyler, Texas, United States, 75702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stryker Trauma and Extremities,

Rebecca Gibson, STUDY_DIRECTOR, Stryker Trauma and Extremities

Study Record Dates

2035-12