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RECRUITING

NCT07044206

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01-28

Completion Date

2029-01

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Disc Degeneration

Interventions

DEVICE

Use of bone substitute during intervertebral fusion surgery

Participants randomized will receive bone substitute during intervertebral fusion surgery. Routine postoperative follow-up procedure (identical for both groups) with two postoperative visits at 3 months and 12 months.

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

Locations (1)

CHU de Montpellier

Montpellier, France, France