Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

Launched by STRYKER TRAUMA AND EXTREMITIES · May 11, 2023

Keywords

ClinConnect Summary

The Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is researching a specific shoulder device called the Shoulder iD™. The study aims to understand how well this device works and how safe it is for adults who have severe shoulder problems, particularly those with non-repairable rotator cuff tears. Researchers want to find out how much patients' shoulder function improves two years after surgery and how often patients might need additional surgeries over a ten-year period.

To be eligible to participate, you need to be at least 18 years old and considered a good candidate for shoulder surgery with this device. It’s important that you can follow the study rules and attend regular check-ups with your surgeon. During these visits, you will have tests like x-rays to check on your shoulder and answer questions about how you feel after the surgery. This study is currently looking for participants, and it’s a chance to help improve shoulder care for others in the future.

Gender

ALL

Eligibility 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