Orthopedic DisorderBLUEMRNCT06080412
Blueprint® Mixed Reality Pilot Study
An observational study of Orthopedic Disorder and Arthritis Shoulder, run by Stryker Trauma and Extremities at 4 sites in France.
Trial 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™). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder, Arthritis Shoulder, Arthritis, Degenerative
- How many people
- 44 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Feb 2024to 7 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
France4 sites
APHP Ambroise Paré
Boulogne-Billancourt
CHU de Brest
Brest
Centre Orthopédique Santy
Lyon, 69008
CHU de Tours
Tours
About this study
Official title: 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™).
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™).
Read the detailed 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.
- Conditions
- Orthopedic Disorder, Arthritis Shoulder, Arthritis, Degenerative, Cuff Tear Arthropathy, Cuff Rotator Full Thickness Tear
- Medical subject headings
- Musculoskeletal Diseases, Osteoarthritis, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days after surgery
Secondary outcomes (7)
DURATION OF THE INTERVENTION
Duration of each planning period and of each subsequent surgical intervention.
Measured: Surgery
FUNCTIONAL EVALUATION AT 6 MONTHS (Range of motion)
Measure the range of motion (in degrees) of the operated shoulder and compare it to the baseline (preoperative) range of motion. Measures will be performed on anonymized photos of patients by an independent central reviewer.
Measured: 6 months after surgery
FUNCTIONAL EVALUATION AT 6 MONTHS (ASES Score)
The American Shoulder and Elbow Surgeons (ASES) score is based on a 100-point scale that incorporates both pain and function. Higher scores indicate higher quality of shoulder function.
This assessment will be conducted at the 6-month postoperative visit and compared with the score obtained before surgery
Measured: 6 months after surgery
PAIN EVALUATION AT 6 MONTHS (ASES Score)
The American Shoulder and Elbow Surgeons (ASES) score is based on a 100-point scale that incorporates both pain and function. Shoulder pain will be analyzed from the pain visual analog scale included in this assessment.
This assessment will be conducted at the 6-month postoperative visit and compared with the score obtained before surgery
Measured: 6 months after surgery
FUNCTIONAL EVALUATION AT 6 MONTHS (Constant score)
The Constant Score is based on a 100-point scale. It incorporates subjective pain measurements and questions regarding the function of the shoulder with normal daily activities. Higher scores indicate a higher quality of shoulder function.
This assessment will be conducted at the 6-month postoperative visit and compared with the score obtained before surgery
Measured: 6 months after surgery
FUNCTIONAL EVALUATION AT 6 MONTHS (SANE score)
The Single Assessment Numeric Value (SANE) score is a single-question outcome measure that asks subjects to rate their shoulder function, on a scale of 0 to 100. Higher scores indicate a higher quality of shoulder function.
This assessment will be conducted at the 6-month postoperative visit and compared with the score obtained before surgery
Measured: 6 months after surgery
SAFETY EVALUATION
Safety measures will be evaluated throughout the patient's participation in the study.
Adverse events will be evaluated from inclusion to last follow-up and will be documented during the study and categorized as whether they are serious and whether they are related to the study device or procedure.
The following adverse events will be collected:
- Adverse Device Effect (ADE)
- Adverse Event of Special Interest (AESI)
- Serious Adverse Event (SAE)
- Serious Adverse Device Effect (SADE)
Measured: Up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start8 Feb 2024
- Primary completion14 Aug 2024
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma and Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080412
- Sponsor's protocol ID
- UE-03-2022
- Acronym
- BLUEMR
- Status last verified
- Sep 2025
- First submitted
- 6 Jul 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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™).
- ClinicalTrials.gov ID
- NCT06080412
- Acronym / sponsor ID
- BLUEMR / UE-03-2022
- Conditions
- Orthopedic Disorder, Arthritis Shoulder, Arthritis, Degenerative, Cuff Tear Arthropathy, Cuff Rotator Full Thickness Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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™).
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PERFORMANCE MEASUREMENT: Glenoid Implant Placement Accuracy
Time frame: 15 days after surgery
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.
7 secondary outcomes
DURATION OF THE INTERVENTION
Time frame: Surgery
FUNCTIONAL EVALUATION AT 6 MONTHS (Range of motion)
Time frame: 6 months after surgery
FUNCTIONAL EVALUATION AT 6 MONTHS (ASES Score)
Time frame: 6 months after surgery
PAIN EVALUATION AT 6 MONTHS (ASES Score)
Time frame: 6 months after surgery
FUNCTIONAL EVALUATION AT 6 MONTHS (Constant score)
Time frame: 6 months after surgery
FUNCTIONAL EVALUATION AT 6 MONTHS (SANE score)
Time frame: 6 months after surgery
SAFETY EVALUATION
Time frame: Up to 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma and Extremities
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder and Arthritis Shoulder, run by Stryker Trauma and Extremities at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERFORMANCE MEASUREMENT: Glenoid Implant Placement Accuracy (time frame: 15 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.