A Pre-market, Open-label, Single-arm Study to Evaluate b.Bone for Posterolateral Fusion Treatment of Degenerative Thoracolumbar, Lumbar or Lumbosacral Spinal Disease.

GreenBone Ortho S.p.A.2 sites in 2 countries16 target enrollmentAugust 1, 2023

ConditionsDegenerative Spinal Conditions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Spinal Conditions
Sponsor: GreenBone Ortho S.p.A.
Enrollment: 16
Locations: 2
Primary Endpoint: Successful fusion rate by CT scan assessments after surgery.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal conditions, in terms of performance and safety.

Subjects who meet the study selection will undergo up to a three-level posterolateral fusion using b.Bone in combination with autologous bone in a 1:1 ratio. Subjects will be followed up at discharge, week 6, Month 3, Month 6, and Month 12.

Registry

clinicaltrials.gov

Start Date

August 1, 2023

End Date

February 18, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GreenBone Ortho S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patient ≥ 18 years old.
•Patients requiring posterolateral fusion treatment for degenerative thoracolumbar, lumbar, or lumbosacral spinal conditions up to 8 levels.
•Patients willing and able to attend the follow-up visits and procedures foreseen by the study protocol.
•Patients who have provided written informed consent to participate in the study and the processing of personal data before any study procedure is performed.

Exclusion Criteria

•Any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s).
•Patients who have been treated with chemotherapy or radiotherapy within 12 months before the enrolment.
•Indication for spinal fusion because of an acute traumatic reason, like a spinal fracture.
•Bone infection.
•Bone malignant tumor(s).
•Concomitant infectious systemic diseases,
•Inflammatory systemic diseases,
•Concomitant myeloproliferative disorders,
•Active autoimmune disease,
•Known or suspected allergy or hypersensitivity to the b.Bone device components,

Outcomes

Primary Outcomes

Successful fusion rate by CT scan assessments after surgery.

Time Frame: 12 months

Secondary Outcomes

Quality of life assessed by Health Questionnaire(Baseline, 6 weeks, 3, 6, and 12 months post-treatment.)
Successful fusion rate by CT scan assessments after surgery.(6 months)
Functional activity assessed by Oswestry Disability Index.(Baseline, 6 weeks, 3, 6, and 12 months post-treatment.)
Back and Leg pain assessed by Visual Analog Scale.(Baseline, 6 weeks, 3, 6, and 12 months post-treatment.)
Rate of Adverse Events through the clinical trial period.(Up to 12 months)
Neurological function(Baseline, 3, 6, and 12 months post-treatment.)