ACTIVE_NOT_RECRUITING

Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Quick Facts

Study Start:2023-10-20
Study Completion:2035-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05868148

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older at the time of the informed consent or non-opposition (when applicable).
  2. * Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
  3. * Willing and able to comply with the requirements of the study protocol.
  4. * Considered a candidate for shoulder arthroplasty using a study device.
  5. * Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
  1. * 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).
  2. * 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).
  3. * Active local or systemic infection, sepsis, or osteomyelitis
  4. * 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)
  5. * Significant injury to the brachial plexus
  6. * Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the device components
  7. * Neuromuscular disease (e.g., joint neuropathy) Known allergy to one of the product materials
  8. * Metabolic disorders which may impair bone formation

Contacts and Locations

Principal Investigator

Rebecca Gibson
STUDY_DIRECTOR
Stryker Trauma and Extremities

Study Locations (Sites)

UCSF
San Francisco, California, 94158
United States
Jameson Crane Sports Medicine Institute OSU
Columbus, Ohio, 43202
United States
UT Southwestern
Frisco, Texas, 75033
United States
UT Health Science center - Houston
Houston, Texas, 77030
United States
Carilion Clinic
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Stryker Trauma and Extremities

  • Rebecca Gibson, STUDY_DIRECTOR, Stryker Trauma and Extremities

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20
Study Completion Date2035-12

Study Record Updates

Study Start Date2023-10-20
Study Completion Date2035-12

Terms related to this study

Keywords Provided by Researchers

  • Massive RCT
  • Non-repairable RCT
  • Glenohumeral joint

Additional Relevant MeSH Terms

  • 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