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

NCT ID: NCT05906394

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-02-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Posterolateral Fusion

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

Group Type: EXPERIMENTAL

Posterolateral Fusion

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GreenBone Ortho S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Barbanti Bròdano, Dr

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Rizzoli, Bologna - Italy

Locations

Klinikum Magdeburg

Magdeburg, , Germany

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Countries

Germany; Italy

Other Identifiers

CIV-23-03-042713

Identifier Type: OTHER

Identifier Source: secondary_id

CIP-P010-0122

Identifier Type: -

Identifier Source: org_study_id