Status:
COMPLETED
Blueprint® Mixed Reality Pilot Study
Lead Sponsor:
Stryker Trauma and Extremities
Collaborating Sponsors:
ClinSearch
Conditions:
Orthopedic Disorder
Arthritis Shoulder
Eligibility:
All Genders
18+ years
Brief 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 HOLOBLUEPRINT™ (HOLOBLUEPRIN...
Detailed Description
The purpose of this clinical investigation is to assess performance by collecting post-market performance and safety data. Outcome data collected from this pilot clinical investigation will provide de...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 7 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06080412
Start Date
February 8 2024
End Date
May 7 2025
Last Update
September 16 2025
Active Locations (4)
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1
APHP Ambroise Paré
Boulogne-Billancourt, France
2
CHU de Brest
Brest, France
3
Centre Orthopédique Santy
Lyon, France, 69008
4
CHU de Tours
Tours, France