Actively Recruiting
Comparative Study of Two Osteoinductive Bioactive Bone Substitutes for Anterior Lumbar Interbody Fusion in Adults with Degenerative Lumbar Disc Disease
Led by University Hospital, Montpellier · Updated on 2026-03-11
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Disc degeneration causes worsening damage to the intervertebral discs, leading to significant low back pain and reduced mobility that impacts daily life. This condition is often related to aging and worsened by injuries, lifestyle, and genetics. Surgery involving spinal fusion with an interbody implant and bone graft is a common treatment for advanced cases. This research compares a new bioactive bone substitute, based on osteo-immunology technology (MagnetOs, Kuros), to traditional bone grafts and other substitutes to evaluate its effects on bone fusion and functional recovery in adults with degenerative lumbar disc disease. Participants will undergo anterior lumbar interbody fusion surgery using either the new bone substitute (Magnetos Putty, Kuros) or a conventional bone substitute (GlassBone Putty, Noraker). The study randomly assigns 100 adult patients to one of these two groups. The surgical procedure is standard except for the bone substitute used. The study includes visits before surgery, on surgery day, and follow-ups at 3 and 12 months post-surgery, with imaging and assessments to monitor fusion progress and recovery. During the study, participants will have health questionnaires, pain and disability evaluations using the Visual Analog Scale and Oswestry Disability Index, and imaging tests including CT scans and X-rays. Researchers will collect data on pain levels, functional ability, medication use, return to work, and any reoperations or hospitalizations. The main outcome is the change in disability score from before surgery to one year after. Safety and functional improvements will be closely monitored throughout the year-long follow-up.
CONDITIONS
Brief 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) score greater than 25
- Chronic low back pain and/or radicular pain lasting 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 lumbar spinal fusion surgery with interbody cage
You will not qualify if you...
- History of lumbar spinal surgery excluding isolated discectomies for disc herniation
- Confirmed osteoporosis
- Previous surgical fusion at an adjacent spinal level
- Contraindications to Magnetos Putty or GlassBone Putty including use of medications affecting calcium metabolism
- Severe systemic or metabolic bone disorders impacting healing
- Untreated acute or chronic infections requiring therapy
- Severe trauma or open wounds near the surgical site
- Known allergy to bioactive glass components, polyethylene glycol, or glycerol
- Undergoing or planned chemotherapy or radiotherapy near implantation site
- Severe kidney or liver infections
- Unrepaired dural tear from craniospinal surgery
- Requirement for placement of more than one implant
- Inability to read or write fluent French
- Participation in another conflicting interventional trial
- Uncontrolled psychiatric illness
- Lack of written informed consent
- Dependency or employment relationship with study sponsor or investigator
- Enrollment in another study with exclusion period
- Not affiliated with or beneficiary of French social security system
- Protected populations including pregnant or breastfeeding women, individuals deprived of liberty, or under legal protection
- Women planning pregnancy within one year
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits including a preoperative consultation between 6 months and 1 month before surgery, and a screening and enrollment visit the day before surgery
Duration - 1 day
Participants undergo anterior lumbar interbody fusion surgery with the assigned bone substitute.
1 surgical intervention visit on Day 0
Duration - 12 months
Participants attend follow-up visits to assess pain, function, and spinal fusion progress after surgery.
2 visits at 3 months and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
CHU de Montpellier
Montpellier, France, France, 34295
Actively Recruiting
Research Team
N
Nicolas LONJON, MD, PhD
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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