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

GreenBone Ortho

Status: Completed

Conditions: Degenerative Spinal Conditions

Treatments: Procedure: Posterolateral Fusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT05906394

CIV-23-03-042713 (Other Identifier)

CIP-P010-0122

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Posterolateral Fusion

Experimental group

Description:

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

Treatment:

Procedure: Posterolateral Fusion