Trials Sponsors Conditions Drugs Pricing

Conditions

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

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

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.

Sponsors & Collaborators

ClinSearch
Othercollaborator
Stryker Trauma and Extremities
Industrylead

Study Sites (4)

APHP Ambroise Paré

Boulogne-Billancourt, France

CHU de Brest

Brest, France

Centre Orthopédique Santy

Lyon, 69008, France

CHU de Tours

Tours, France

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

Enrollment

44 participants (actual enrollment reported by the registry).

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

Actual (reported)

Blueprint® Mixed Reality Pilot Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Blueprint Mixed Reality HOLOBLUEPRINT™ in Reversed Shoulder replacement

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Blueprint Mixed Reality HOLOBLUEPRINT™ in Reversed Shoulder replacement

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations