Evaluating the safety and effectiveness of a mixed reality surgical planning tool for shoulder surgery

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™ (HOLOBLUEPRINT™).

This study is testing a new mixed reality tool to see if it makes shoulder surgery safer and more effective for patients.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stryker Trauma and Extremities (Industry-sponsored)
• Locations: 4 sites (Boulogne-Billancourt and 3 other locations)
• Trial ID: NCT06080412 on ClinicalTrials.gov

What this trial studies

This pilot clinical investigation aims to assess the performance and safety of the Blueprint Mixed Reality HOLOBLUEPRINT™ in patients undergoing shoulder arthroplasty. The study will collect data from 50 subjects across four sites in France, focusing on post-market performance and safety over a six-month follow-up period. Patients will be enrolled consecutively, ensuring a robust data collection process while minimizing selection bias. Data will be gathered preoperatively, during surgery, and at a follow-up visit two weeks post-surgery, with additional assessments at six months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for shoulder arthroplasty using the HOLOBLUEPRINT™ system.

Not a fit: Patients who are unable to comply with study procedures or belong to vulnerable groups may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance surgical outcomes and patient safety in shoulder arthroplasty procedures.

How similar studies have performed: While this approach is innovative, similar studies using mixed reality in surgical planning have shown promising results, indicating potential for success.

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).

Where this trial is running

Boulogne-Billancourt and 3 other locations

• APHP Ambroise Paré — Boulogne-Billancourt, France (Recruiting)
• CHU de Brest — Brest, France (Recruiting)
• Centre Orthopédique Santy — Lyon, France (Recruiting)
• CHU de Tours — Tours, France (Recruiting)

Study contacts

• Study coordinator: Amjad Uneisi

Conditions Orthopedic Disorder; Arthritis Shoulder; Arthritis, Degenerative; Cuff Tear Arthropathy; Cuff Rotator Full Thickness Tear