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Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Study acronym: SiD
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv11
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 8 to 5v10 Show 1 more changeShow less
    • Study sites: 8 to 5
  3. Study sites: 7 to 8v9
  4. Study sites: 6 to 7v8
  5. Study sites: 5 to 6v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 4 to 5v6
  2. Study sites: 3 to 4v5
  3. Site details revised at 1 of 3 sitesv4
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Oct 2023 to Oct 20, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Oct 2023 to Oct 20, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05868148
Lead Sponsor Stryker Trauma and Extremities
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
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov