Comparing two bioactive bone substitutes to help spinal fusion after anterior lumbar surgery
Prospective Randomized Comparative Study of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults
This trial tests two osteoinductive bioactive bone substitutes to see which better helps adults with degenerative lumbar disc disease achieve spinal fusion after anterior lumbar interbody surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Montpellier, France) |
| Trial ID | NCT07044206 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial enrolls adults with degenerative lumbar disc disease who are scheduled for anterior lumbar interbody arthrodesis and compares two osteoinductive bioactive bone substitutes placed inside the interbody implant. Participants receive one of the two bone substitute putties at the time of surgery and are followed with clinical assessments and imaging to document fusion, pain, and disability. Primary outcomes include radiographic fusion rates and clinical measures such as Oswestry Disability Index and pain scores, with monitoring for nonunion and reoperation. The trial is single-center at CHU de Montpellier and excludes patients with conditions that impair bone healing or contraindicate the products.
Who should consider this trial
Good fit: Adults 18–80 with chronic low back and/or radicular pain >6 months, ODI >25, failed conservative treatment, and eligible for anterior lumbar interbody fusion for disc degeneration or grade 1 spondylolisthesis are ideal candidates.
Not a fit: Patients with prior lumbar fusion, confirmed osteoporosis, active infection, severe metabolic bone disease, or contraindications to the specific bone substitutes are unlikely to benefit from participation.
Why it matters
Potential benefit: If one substitute proves superior, patients could have higher fusion rates, less need for harvesting autologous bone, and fewer reoperations.
How similar studies have performed: Bioactive synthetic bone substitutes are in clinical use and animal data show improved bone formation, but direct head-to-head clinical comparisons of these specific osteoinductive putties are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Patient presenting with one of the following: grade 1 degenerative spondylolisthesis without isthmic lysis, or disc degeneration, or mixed pathology (degeneration and lumbar stenosis) * Patient eligible for anterior approach spinal fusion surgery with interbody cage Exclusion Criteria: * History of spinal surgery at the lumbar level, excluding isolated discectomies for disc herniation * Confirmed osteoporosis * Surgical fusion at an adjacent level * Contraindication to Magnetos Putty or GlassBone Putty: 1. Use of medications interfering with calcium metabolism 2. Severe systemic or metabolic bone disorders affecting bone healing or lesions 3. Untreated acute or chronic infection requiring appropriate therapy 4. Patients with severe trauma and open external wounds near the defect site, at risk of infection 5. Known allergy to bioactive glass or its components (Ca2+, PO43-, Na+, and Si(OH)4), polyethylene glycol, and/or glycerol 6. Patients who have undergone or will undergo chemotherapy or radiotherapy at or near the implantation site 7. Severe renal or hepatic infections 8. Unrepaired dural tear in craniospinal surgery * Patients requiring placement of more than one implant * Subject unable to read and/or write fluent French, or illiterate * Subject already participating in another interventional clinical trial that could interfere with this study * Uncontrolled psychiatric illness * Lack of written informed consent after a reflection period * Individuals with a dependency or employment relationship with the sponsor or investigator * Subject enrolled in another study with an ongoing exclusion period (Article L1121-12) * Subject not affiliated with or not a beneficiary of the French social security system (L1121-8-1) * Protected populations under French Public Health Code: 1. Pregnant or breastfeeding women (L. 1121-5) 2. Individuals deprived of liberty (art. L. 1121-6) (by judicial, administrative decision or involuntary hospitalization) 3. Protected adults (under guardianship, curatorship, or legal protection) (L. 1121-8) * Women planning to become pregnant within the year
Where this trial is running
Montpellier, France
- CHU de Montpellier — Montpellier, France, France (Recruiting)
Study contacts
- Study coordinator: Nicolas LONJON, MD, PhD
- Email: n-lonjon@chu-montpellier.fr
- Phone: +33467337488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.