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

NCT07044206 | Recruiting

• 1 other identifier: RECHMPL23_0450
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disc Degeneration

Keywords

spinal surgery; spinal fusion; intervertebral disc

Outcome Measures

Primary Outcomes (1)

• Change in the Oswestry Disability Index (ODI) score from baseline (preoperative assessment) to 12 months following lumbar spinal fusion surgery for disc degeneration in adult patients.

  The primary efficacy endpoint will assess functional disability improvement by measuring the variation in ODI score between the preoperative evaluation and the 12-month postoperative follow-up. The ODI is a self-administered questionnaire used to assess the degree of disability related to low back pain. It consists of 10 sections, each scored from 0 to 5, resulting in a total score ranging from 0 (no disability) to 50 (maximum disability).

  Baseline to 12 months post-surgery

Secondary Outcomes (8)

• Assessment of interbody fusion at 12 months using CT scan.

  12 months post-surgery

• Evaluation of pain and functional disability using Visual Analog Scale (VAS) for low back and radicular pain at 3 and 12 months postoperatively.

  3 months and 12 months post-surgery

• Oswestry Disability Index (ODI) at 3 and 12 months.

  3 months and 12 months post-surgery

• Use of analgesic and anti-inflammatory medications (steroidal and non-steroidal) at 3 and 12 months postoperatively.

  3 months and 12 months post-surgery

• Rate of patient return to work at 3 and 12 months postoperatively

  3 months and 12 months post-surgery

Study Arms (2)

Intervention group : Interbody fusion with bone substitute Magnetos Putty, Kuros medical

EXPERIMENTAL

Subjects randomly assigned to the intervention group will benefit from Magnetos Putty, Kuros during surgery

Device: Use of bone substitute during intervertebral fusion surgery

Control group : Interbody fusion with conventional bone substitute GlassBone Putty, Noraker

ACTIVE COMPARATOR

Subjects randomly assigned to the control group will benefit from GlassBone Putty, Noraker during surgery

Device: Use of bone substitute during intervertebral fusion surgery

Interventions

Use of bone substitute during intervertebral fusion surgery DEVICE

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.

Control group : Interbody fusion with conventional bone substitute GlassBone Putty, Noraker; Intervention group : Interbody fusion with bone substitute Magnetos Putty, Kuros medical

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, France, 34295, France

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Nicolas LONJON, MD, PhD

CONTACT

+33467337488; n-lonjon@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 29, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

FR (1)