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

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Spinal Conditions
• Intervention / Treatment: Procedure: Posterolateral Fusion

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Magdeburg, Germany
    • Klinikum Magdeburg
• Italy
  • Bologna, Italy
    • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patient ≥ 18 years old.
2. Patients requiring posterolateral fusion treatment for degenerative thoracolumbar, lumbar, or lumbosacral spinal conditions up to 8 levels.
3. Patients willing and able to attend the follow-up visits and procedures foreseen by the study protocol.
4. 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:

1. Any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s).
2. Patients who have been treated with chemotherapy or radiotherapy within 12 months before the enrolment.
3. Indication for spinal fusion because of an acute traumatic reason, like a spinal fracture.
4. Bone infection.
5. Bone malignant tumor(s).
6. Concomitant infectious systemic diseases,
7. Inflammatory systemic diseases,
8. Concomitant myeloproliferative disorders,
9. Active autoimmune disease,
10. Known or suspected allergy or hypersensitivity to the b.Bone device components,
11. Calcium metabolism disorder (i.e. hypercalcemia),
12. Known hyperthyroidism or autonomous thyroid adenoma.
13. Patients currently treated with systemic immunosuppressive agents.
14. 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.
15. Body mass index (BMI) larger than 36 (morbidly obese).
16. Known severe osteoporosis.
17. Patients requiring instrumented fusion in the cervical spine.
18. Woman who is pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Posterolateral Fusion; Patients recruited for clinical investigation will undergo up to a three-level posterolateral fusion (PLF) procedure with b.Bone granules.	Procedure: Posterolateral Fusion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful fusion rate by CT scan assessments after surgery.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Maintenance/improvement of neurological function postoperatively versus baseline.	Baseline, 3, 6, and 12 months post-treatment.
Rate of Adverse Events through the clinical trial period.		Up to 12 months

Collaborators and Investigators

• Sponsor: GreenBone Ortho S.p.A.
• Investigators: Principal Investigator: Giovanni Barbanti Bròdano, Dr, IRCCS Istituto Ortopedico Rizzoli, Bologna - Italy

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): February 18, 2025
• Study Completion (Actual): February 18, 2025

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CIP-P010-0122; CIV-23-03-042713 (Other Identifier: EUDAMED Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No