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Surgeons test High-Tech goggles for better shoulder replacements

NCT ID NCT06080412

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

44 people

The number who actually took part.

Started

Feb 2024

Finished

May 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • APHP Ambroise Paré

    Boulogne-Billancourt, France

  • CHU de Brest

    Brest, France

  • CHU de Tours

    Tours, France

  • Centre Orthopédique Santy

    Lyon, 69008, France

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