NCT05868148Active, not recruiting
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 21 Apr 2023
- Start date
- 20 Oct 2023
- Primary completion date
- Dec 2027
- Lead sponsor
- Stryker Trauma and Extremities
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05868148
What you commit to
- Study type: Observational
- Planned participants: 200
- From 20 Oct 2023 to the primary completion date, Dec 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Active local or systemic infection, sepsis, or osteomyelitis
- Neuromuscular disease (e.g., joint neuropathy) Known allergy to one of the product materials
- Metabolic disorders which may impair bone formation
Other
- 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).
- Significant injury to the brachial plexus
- Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the device components
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jameson Crane Sports Medicine Institute OSU Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| UT Southwestern Coordinator of this site? Confirm its status | Frisco | United States | Unknown status |
| UT Health Science center - Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Carilion Clinic Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.