About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Use of bone substitute during intervertebral fusion surgery