Spinal Fusion Clinical Trials

Clinical trials related to Spinal Fusion Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Nicolas LONJON, MD, PhD
n-lonjon@chu-montpellier.fr
+33467337488
Time Frame
Start Date: 2026-01-28
Estimated Completion Date: 2029-01
Participants
Target number of participants: 100
Treatments
Experimental: Intervention group : Interbody fusion with bone substitute Magnetos Putty, Kuros medical
Subjects randomly assigned to the intervention group will benefit from Magnetos Putty, Kuros during surgery
Active_comparator: Control group : Interbody fusion with conventional bone substitute GlassBone Putty, Noraker
Subjects randomly assigned to the control group will benefit from GlassBone Putty, Noraker during surgery
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov