Actively Recruiting
Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults
Led by University Hospital, Montpellier · Updated on 2026-03-11
100
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 80 years inclusive
- Oswestry Disability Index (ODI) greater than 25
- Chronic low back pain and/or radicular pain lasting for more than 6 months
- Failure of medical and rehabilitative treatment
- Diagnosis of grade 1 degenerative spondylolisthesis without isthmic lysis, disc degeneration, or mixed pathology (degeneration and lumbar stenosis)
- Eligible for anterior approach spinal fusion surgery with interbody cage
You will not qualify if you...
- History of spinal surgery at the lumbar level, excluding isolated discectomies for disc herniation
- Confirmed osteoporosis
- Surgical fusion at an adjacent level
- Contraindications to Magnetos Putty or GlassBone Putty, including use of medications affecting calcium metabolism, severe bone disorders, untreated infections, severe trauma with open wounds near the surgical site, known allergies to components of the bone substitutes, chemotherapy or radiotherapy near implantation site, severe renal or hepatic infections, unrepaired dural tear
- Need for placement of more than one implant
- Inability to read and/or write fluent French or illiteracy
- Participation in another interventional clinical trial that could interfere
- Uncontrolled psychiatric illness
- Lack of written informed consent
- Dependency or employment relationship with the sponsor or investigator
- Enrollment in another study with ongoing exclusion period
- Not affiliated with or beneficiary of French social security system
- Protected populations under French Public Health Code, including pregnant or breastfeeding women, individuals deprived of liberty, protected adults
- Women planning to become pregnant within the year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU de Montpellier
Montpellier, France, France, 34295
Actively Recruiting
Research Team
N
Nicolas LONJON, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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