Clinical trial NCT05906394: A Pre-market Study to Evaluate b.Bone for Posterolateral Fusion (b.Spine 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Spinal Conditions
Lead sponsor: GreenBone Ortho S.p.A.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Successful fusion rate by CT scan assessments after surgery.
timeFrame: 12 months
Secondary outcomes:
measure: Successful fusion rate by CT scan assessments after surgery.
timeFrame: 6 months
measure: Back and Leg pain assessed by Visual Analog Scale.
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
measure: Functional activity assessed by Oswestry Disability Index.
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
measure: Quality of life assessed by Health Questionnaire
timeFrame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
measure: Neurological function
timeFrame: Baseline, 3, 6, and 12 months post-treatment.
measure: Rate of Adverse Events through the clinical trial period.
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
affiliation: IRCCS Istituto Ortopedico Rizzoli, Bologna - Italy
name: Giovanni Barbanti Bròdano, Dr
role: PRINCIPAL_INVESTIGATOR
References: