Evaluating the Shoulder iD™ Primary Reversed Glenoid device for shoulder conditions
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
This study is testing a new shoulder device to see if it helps adults with serious rotator cuff tears feel better and have fewer surgeries over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stryker Trauma and Extremities Industry-sponsored |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT05868148 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to gather safety and performance data on the Shoulder iD™ Primary Reversed Glenoid device in adult patients with massive and non-repairable rotator cuff tears. It will assess patient-reported shoulder function improvements over two years and track the rate of surgical revisions over a ten-year period. Participants will undergo regular check-ups, including imaging and questionnaires, to monitor their shoulder health and device performance. The study is designed as a multicenter, prospective follow-up to evaluate real-world outcomes of this commercially available implant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with massive and non-repairable rotator cuff tears who are suitable for shoulder arthroplasty.
Not a fit: Patients who cannot comply with study procedures or belong to vulnerable groups may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved shoulder function and reduced need for revision surgeries in patients with severe shoulder conditions.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating shoulder arthroplasty devices, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
San Francisco, California and 7 other locations
- UCSF — San Francisco, California, United States (Recruiting)
- Coastal Orthopedics — Bradenton, Florida, United States (Withdrawn)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Jameson Crane Sports Medicine Institute OSU — Columbus, Ohio, United States (Recruiting)
- UT Southwestern — Frisco, Texas, United States (Not_yet_recruiting)
- UT Health Science center - Houston — Houston, Texas, United States (Recruiting)
- CHRISTUS Mother Frances Research — Tyler, Texas, United States (Recruiting)
- Carilion Clinic — Roanoke, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Shawna Brown
- Email: shawna.brown@stryker.com
- Phone: +31 6 25 02 79 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.