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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
Klinikum Magdeburg
Magdeburg, Germany
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy
Successful fusion rate by CT scan assessments after surgery.
Time frame: 12 months
Successful fusion rate by CT scan assessments after surgery.
Time frame: 6 months
Back and Leg pain assessed by Visual Analog Scale.
Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Functional activity assessed by Oswestry Disability Index.
Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Quality of life assessed by Health Questionnaire
Time frame: Baseline, 6 weeks, 3, 6, and 12 months post-treatment.
Neurological function
Maintenance/improvement of neurological function postoperatively versus baseline.
Time frame: Baseline, 3, 6, and 12 months post-treatment.
Rate of Adverse Events through the clinical trial period.
Time frame: Up to 12 months
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