Blueprint® Mixed Reality Pilot Study (NCT06080412) | Clinical Trial Compass
CompletedNot Applicable
Blueprint® Mixed Reality Pilot Study
France44 participantsStarted 2024-02-08
Plain-language summary
A pilot Single-Arm, Multicenter, Prospective, Post-Market 6 months Follow-Up Clinical Investigation to Evaluate the Safety and Effectiveness of the Blueprint Mixed Reality HOLOBLUEPRINTâ„¢ (HOLOBLUEPRINTâ„¢).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 BluePrintâ„¢ 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).