RecruitingNot ApplicableNCT07044206

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

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

Sponsor

University Hospital, Montpellier

Enrollment

100 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Disc Degeneration

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria25

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:
Use of medications interfering with calcium metabolism
Severe systemic or metabolic bone disorders affecting bone healing or lesions
Untreated acute or chronic infection requiring appropriate therapy
Patients with severe trauma and open external wounds near the defect site, at risk of infection
Known allergy to bioactive glass or its components (Ca2+, PO43-, Na+, and Si(OH)4), polyethylene glycol, and/or glycerol
Patients who have undergone or will undergo chemotherapy or radiotherapy at or near the implantation site
Severe renal or hepatic infections
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:
Pregnant or breastfeeding women (L. 1121-5)
Individuals deprived of liberty (art. L. 1121-6) (by judicial, administrative decision or involuntary hospitalization)
Protected adults (under guardianship, curatorship, or legal protection) (L. 1121-8)
Women planning to become pregnant within the year

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Interventions

DEVICEUse 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.