Clinical trial NCT06080412: Blueprint® Mixed Reality Pilot 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™).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthopedic Disorder
Arthritis Shoulder
Arthritis, Degenerative
Cuff Tear Arthropathy
Cuff Rotator Full Thickness Tear
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
First posted: 2023-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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™).

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.

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).

Primary outcomes:
measure: PERFORMANCE MEASUREMENT: Glenoid Implant Placement Accuracy
timeFrame: 15 days after surgery
Secondary outcomes:
measure: DURATION OF THE INTERVENTION
timeFrame: Surgery
measure: FUNCTIONAL EVALUATION AT 6 MONTHS (Range of motion)
timeFrame: 6 months after surgery
measure: FUNCTIONAL EVALUATION AT 6 MONTHS (ASES Score)
timeFrame: 6 months after surgery
measure: PAIN EVALUATION AT 6 MONTHS (ASES Score)
timeFrame: 6 months after surgery
measure: FUNCTIONAL EVALUATION AT 6 MONTHS (Constant score)
timeFrame: 6 months after surgery
measure: FUNCTIONAL EVALUATION AT 6 MONTHS (SANE score)
timeFrame: 6 months after surgery
measure: SAFETY EVALUATION
timeFrame: Up to 6 months after surgery
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: APHP Ambroise Paré
city: Brest
country: France
facility: CHU de Brest
city: Lyon
country: France
facility: Centre Orthopédique Santy
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: Stryker Trauma and Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: