Disc degeneration is a progressive deterioration process of the intervertebral disc, which can manifest as significant low back pain and a loss of mobility that interferes with daily activities. This condition is naturally age-related and exacerbated by traumatic events, lifestyle factors, and individual genetic susceptibilities. Treatment for advanced disc degeneration typically involves surgery (spinal fusion) aimed at addressing and fusing the affected intervertebral discs using an interbody implant combined with a bone graft.
Although the use of interbody implants promotes temporary fusion, long-term success largely depends on the bone substitute used, with failure rates ranging from 10 to 20% (unsuccessful fusion, persistent symptoms, need for reoperation). Historically, autologous bone grafting was the standard, but it carries disadvantages related to pain and invasiveness. Synthetic, bioactive bone substitutes are now used, although their effectiveness varies.
Animal studies support the hypothesis that a new substitute based on specific osteo-immunology technology (MagnetOs, Kuros) could offer superior results compared to autologous bone grafts and competing osteo-inductive materials, while being minimally invasive. This study aims to evaluate its properties in terms of bone fusion and its impact on functional scores in patients, hypothesizing a significant improvement in fusion rates and functional scores with this new substitute.
Patients aged between 18 and 80 years inclusive
Oswestry Disability Index (ODI) >25
Chronic low back pain and/or radicular pain lasting for more than 6 months
Failure of medical and rehabilitative treatment
History of spinal surgery at the lumbar level, excluding isolated discectomies for disc herniation
Confirmed osteoporosis
Surgical fusion at an adjacent level
Use of medications interfering with calcium metabolism
Parallel
Use of bone substitute during intervertebral fusion surgery
DeviceParticipants randomized will receive bone substitute during intervertebral fusion surgery. Routine postoperative follow-up procedure (identical for both groups) with two postoperative visits at 3 months and 12 months.
Change in the Oswestry Disability Index (ODI) score from baseline (preoperative assessment) to 12 months following lumbar spinal fusion surgery for disc degeneration in adult patients.
The primary efficacy endpoint will assess functional disability improvement by measuring the variation in ODI score between the preoperative evaluation and the 12-month postoperative follow-up. The ODI is a self-administered questionnaire used to assess the degree of disability related to low back pain. It consists of 10 sections, each scored from 0 to 5, resulting in a total score ranging from 0 (no disability) to 50 (maximum disability).
Assessment of interbody fusion at 12 months using CT scan.
The assessment of fusion grade is performed in a blinded manner by two trained readers (a neuroradiologist and a neurosurgeon), based on consensus. Evaluation is conducted using a high-resolution (millimetric) lumbar CT scan performed 12 months after the surgical procedure. The results are classified into three grades: definite fusion, uncertain fusion, and definite pseudarthrosis.
Evaluation of pain and functional disability using Visual Analog Scale (VAS) for low back and radicular pain at 3 and 12 months postoperatively.
Pain intensity will be assessed using the Visual Analog Scale (VAS) for both low back and radicular pain. This score will be recorded at 3-month and 12-month follow-up visits to evaluate the evolution of symptoms over time. The VAS is a patient-reported measure used to quantify pain intensity ranging from 0 to 10. A score of 0 indicates no pain, a score of 10 represents the worst possible pain.
Oswestry Disability Index (ODI) at 3 and 12 months.
Functional disability will be measured using the Oswestry Disability Index (ODI). This score will be recorded at 3-month and 12-month follow-up visits to evaluate functional recovery over time.
Use of analgesic and anti-inflammatory medications (steroidal and non-steroidal) at 3 and 12 months postoperatively.
Evaluation of postoperative consumption of pain medications, including steroidal and non-steroidal anti-inflammatory drugs (NSAIDs), at the 3-month and 12-month follow-up visits.
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