Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Montpellier

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

Treatment groups

100 Participants
are divided into 2 treatment groups