Blueprint® Mixed Reality Pilot Study

Last updated: November 26, 2024
Sponsor: Stryker Trauma and Extremities
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Musculoskeletal Diseases

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT06080412
UE-03-2022
  • Ages > 18
  • All Genders

Study 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™ (HOLOBLUEPRINT™).

Eligibility Criteria

Inclusion

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™ 3Dplanning software and shoulder system:

  • Humeral side: Tornier Perform Humeral Stem

  • Glenoid side: Tornier Perform Reversed Glenoid

Exclusion

Exclusion Criteria:

  • Inability to comply with the pilot clinical investigation procedures based on thejudgment of the assessor (e.g. unable to accurately respond to the pilot clinicalinvestigation questionnaires, and inability to attend the scheduled assessments);

  • The subjects belong to a vulnerable group of subjects, including minors, thoseunable to decide for themselves to participate or needing a Legally AuthorizedRepresentative (LAR), or others who could be subject to coercion (subjects who maynot 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., metallicdevice close to the shoulder).

Study Design

Total Participants: 50
Study Start date:
February 08, 2024
Estimated Completion Date:
May 08, 2025

Study 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 descriptive data on performance and safety for Post-Market Surveillance (PMS) reporting, Clinical investigation Reports (CIR), and Clinical Evaluation Reports (CER).

This France-based pilot clinical investigation will include 4 investigating sites.

The sponsors are seeking to enroll 50 subjects undergoing surgery using HOLOBLUEPRINT™. The inclusion period is expected to take approximately 3 months, at an estimated rate of 13 subjects/month.

In case of implant size difference or necessary changes between the preoperative planning and the actual device implanted, the patient will be excluded (Screen Failure) and no analysis will be performed.

Each time an enrolled patient is operated using HOLOBLUEPRINT™, the site must enroll this patient consecutively, assuming the patient meets inclusion/non-inclusion criteria and provides their signed informed consent to participate (according to local requirements). This process of consecutive enrollment is one means of preventing patient selection bias and should strengthen the value of data collected in the pilot clinical investigation.

Data will be collected preoperatively (baseline), during the surgical intervention, and in the immediate postoperative period (no later than 2 weeks postoperative). Then, a 6-month postoperative visit will complete the patient's participation in the pilot clinical investigation. At any time over the course of the clinical investigation, any adverse events will be recorded; both severity and a possible link to the clinical investigation device will be examined.

The device included in the scope of this pilot clinical investigation is commercially available in Europe: Blueprint Mixed Reality HOLOBLUEPRINT™ used in combination with Blueprint Mixed Reality instruments.

Connect with a study center

  • APHP Ambroise Paré

    Boulogne-Billancourt,
    France

    Active - Recruiting

  • CHU de Brest

    Brest,
    France

    Active - Recruiting

  • Centre Orthopédique Santy

    Lyon, 69008
    France

    Active - Recruiting

  • CHU de Tours

    Tours,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.