A Pre-market Study to Evaluate b.Bone for Posterolateral Fusion (b.Spine Clinical Trial).

NCT05906394 | Completed DMC

• 2 other identifiers: CIP-P010-0122CIV-23-03-042713
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 2

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.

Conditions

Degenerative Spinal Conditions

Outcome Measures

Primary Outcomes (1)

• Successful fusion rate by CT scan assessments after surgery.

  12 months

Secondary Outcomes (6)

• Successful fusion rate by CT scan assessments after surgery.

  6 months

• Back and Leg pain assessed by Visual Analog Scale.

  Baseline, 6 weeks, 3, 6, and 12 months post-treatment.

• Functional activity assessed by Oswestry Disability Index.

  Baseline, 6 weeks, 3, 6, and 12 months post-treatment.

• Quality of life assessed by Health Questionnaire

  Baseline, 6 weeks, 3, 6, and 12 months post-treatment.

• Neurological function

  Baseline, 3, 6, and 12 months post-treatment.

Study Arms (1)

Posterolateral Fusion

EXPERIMENTAL

Patients recruited for clinical investigation will undergo up to a three-level posterolateral fusion (PLF) procedure with b.Bone granules.

Procedure: Posterolateral Fusion

Interventions

Posterolateral Fusion PROCEDURE

Posterolateral spinal fusion is a neurosurgical or orthopaedic surgical technique that joins two or more vertebrae. This procedure can be performed at any level in the spine (cervical, thoracic, lumbar, or sacral) and prevents any movement between the fused vertebrae.

Posterolateral Fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Calcium metabolism disorder (i.e. hypercalcemia),
• Known hyperthyroidism or autonomous thyroid adenoma.
• Patients currently treated with systemic immunosuppressive agents.
• Patients who are currently enrolled in another clinical study that would directly interfere with the current study, except when the patient is participating in a purely observational registry with no associated treatments.
• Body mass index (BMI) larger than 36 (morbidly obese).

Sponsors & Collaborators

• GreenBone Ortho S.p.A.: lead

Study Sites (2)

Klinikum Magdeburg

Magdeburg, Germany

Location

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy

Location

Study Officials

• Giovanni Barbanti Bròdano, Dr

  IRCCS Istituto Ortopedico Rizzoli, Bologna - Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: August 1, 2023
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1)