b.Spine Clinical Trial

Degenerative Spinal Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906394
• Other study ID #: CIP-P010-0122
• Secondary ID: CIV-23-03-042713
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: GreenBone Ortho S.p.A.
• Contact: Sonia Esmeralda Granados Reyes, MSc
• Phone: +393450954463
• Email: sonia.granados[@]greenbone.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Spinal Conditions

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinikum Magdeburg	Magdeburg
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
GreenBone Ortho S.p.A.

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful fusion rate by CT scan assessments after surgery.		12 months
Secondary	Successful fusion rate by CT scan assessments after surgery.		6 months
Secondary	Back and Leg pain assessed by Visual Analog Scale.		Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Secondary	Functional activity assessed by Oswestry Disability Index.		Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Secondary	Quality of life assessed by Health Questionnaire		Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Secondary	Neurological function	Maintenance/improvement of neurological function postoperatively versus baseline.	Baseline, 3, 6, and 12 months post-treatment.
Secondary	Rate of Adverse Events through the clinical trial period.		Up to 12 months