Surgeons test High-Tech goggles for better shoulder replacements
NCT ID NCT06080412
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a mixed reality system called HOLOBLUEPRINT that helps surgeons see 3D plans during shoulder replacement surgery. 44 adults having shoulder surgery used the tool. Researchers checked if the implant was placed accurately by comparing CT scans before and after surgery. The goal was to see if the tool is safe and helpful.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HOLOBLUEPRINT mixed reality system (a software tool used during surgery)
- What this could lead to
- If successful, this tool could help surgeons place shoulder implants more accurately, potentially improving surgical outcomes.
- What could go wrong
- This is a small, early pilot study with only 44 participants and no comparison group. The results may not apply to all patients or surgeons.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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44 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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May 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with shoulder's condition requiring a shoulder surgery with a reversed implants. 50 patients are planned to be included in the study.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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APHP Ambroise Paré
Boulogne-Billancourt, France
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CHU de Brest
Brest, France
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CHU de Tours
Tours, France
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Centre Orthopédique Santy
Lyon, 69008, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Sensor-Aided rehab could transform knee replacement recovery
- Knee surgery showdown: which tendon graft works best?
- Should you rehab early after shoulder replacement? small study aims to find out
- Shoulder surgery showdown: which replacement works best?