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New treatment option for Disc Degeneration
Official title Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults
ClinicalTrials.gov ID: NCT07044206
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
You likely can't join 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
See the full eligibility 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.