Blueprint® Mixed Reality Pilot Study

Launched by STRYKER TRAUMA AND EXTREMITIES · Oct 5, 2023

Keywords

ClinConnect Summary

The Blueprint® Mixed Reality Pilot Study is a clinical trial looking at a new technology called HOLOBLUEPRINT™. This study aims to see if using this mixed reality tool can help make shoulder surgeries safer and more effective for people with certain shoulder problems, like arthritis and rotator cuff tears. The trial is currently recruiting participants who are 18 years or older and are considered suitable candidates for shoulder replacement surgery using specific tools and planning software.

If you decide to participate, you'll need to provide informed consent and follow the study guidelines. The trial will involve monitoring your progress over six months after your surgery. It's important to note that there are some exclusions, such as being unable to follow study procedures or having certain medical conditions. Overall, this study represents an exciting opportunity to help improve treatments for shoulder disorders using innovative technology.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older at the time of the informed consent.
• • Informed and willing to sign an informed consent approved by Ethics Committee
• • Willing and able to comply with the requirements of the study protocol
• * Considered a candidate for on label shoulder arthroplasty using BluePrint™ 3D planning software and shoulder system:
• • Humeral side: Tornier Perform Humeral Stem
• • Glenoid side: Tornier Perform Reversed Glenoid
• Exclusion Criteria:
• • Inability to comply with the pilot clinical investigation procedures based on the judgment of the assessor (e.g. unable to accurately respond to the pilot clinical investigation questionnaires, and inability to attend the scheduled assessments);
• • The subjects belong to a vulnerable group of subjects, including minors, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (subjects who may not be acting on their initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm);
• • Any medical condition that could impact the pilot clinical investigation outcomes' functional significance, at the investigator's discretion (e.g., neuropathy, allergy);
• • Bio RSA (Bone graft (Autograft))
• • Subject pregnancy;
• • Subjects incompatible with Blueprint®'s intended use and CT Protocol (e.g., metallic device close to the shoulder).