Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT06080412 En recrutement

Titre

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™). (BLUEMR)

Type

Observational

Pathologie

Arthropathie de rupture de la coiffe des rotateurs
Arthrite
Maladies ostéomusculaires
Arthrose

Phase

Promoteur

Stryker Trauma and Extremities (Voir sur ClinicalTrials)

Date de début

février 2024

Date de fin

mai 2025

Dernière mise à jour

03 décembre 2024

Résumé

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™).

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
APHP Ambroise Paré - Boulogne-Billancourt - France	Jean David WERTHEL, MD	En recrutement	Contact (sur clinicalTrials)
Centre Orthopédique Santy - 69008 - Lyon - France	Sophie Plantier	En recrutement	Contact (sur clinicalTrials)
CHU de Brest - Brest - France	Hoel LETISSIER, MD	En recrutement	Contact (sur clinicalTrials)
CHU de Tours - Tours - France	Julien BERHOUET, MD	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'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™ 3D
planning software and shoulder system:

- Humeral side: Tornier Perform Humeral Stem

- Glenoid side: Tornier Perform Reversed Glenoid

Critère de non inclusion

- 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).

NCT06080412 - 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™). (BLUEMR)

Informations générales
Etablissements
Critères
Accès à la fiche NCT

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