NCT06080412

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™ (HOLOBLUEPRINT™).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2022

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

July 6, 2022

Last Update Submit

September 9, 2025

Conditions

Orthopedic DisorderArthritis ShoulderArthritis, DegenerativeCuff Tear ArthropathyCuff Rotator Full Thickness Tear

Outcome Measures

Primary Outcomes (1)

  • PERFORMANCE MEASUREMENT: Glenoid Implant Placement Accuracy

    To describe the performance of HOLOBLUEPRINT™ by measuring the difference between postoperative implant placement compared with preoperative simulated implant placement. This will be performed using CT scans and a validated internally developed semi-automated software to compare the postoperative images with the preoperative planning.

    15 days after surgery

Secondary Outcomes (7)

  • DURATION OF THE INTERVENTION

    Surgery

  • FUNCTIONAL EVALUATION AT 6 MONTHS (Range of motion)

    6 months after surgery

  • FUNCTIONAL EVALUATION AT 6 MONTHS (ASES Score)

    6 months after surgery

  • PAIN EVALUATION AT 6 MONTHS (ASES Score)

    6 months after surgery

  • FUNCTIONAL EVALUATION AT 6 MONTHS (Constant score)

    6 months after surgery

  • +2 more secondary outcomes

Study Arms (1)

Blueprint Mixed Reality HOLOBLUEPRINT™ in Reversed Shoulder replacement

One single cohort of patients receiving a reversed shoulder arthroplasty with the use of Blueprint Mixed Reality HOLOBLUEPRINT™ as per standard of care.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with shoulder's condition requiring a shoulder surgery with a reversed implants. 50 patients are planned to be included in the study.

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

APHP Ambroise Paré

Boulogne-Billancourt, France

Location

CHU de Brest

Brest, France

Location

Centre Orthopédique Santy

Lyon, 69008, France

Location

CHU de Tours

Tours, France

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesOsteoarthritisRotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesRheumatic DiseasesChondrocalcinosisCrystal Arthropathies

Study Officials

  • Rebecca Gibson

    Stryker Trauma and Extremities

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

October 12, 2023

Study Start

February 8, 2024

Primary Completion

August 14, 2024

Study Completion

May 7, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)