Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT07044206
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07044206
Study Brief:
Protocol Section:
NCT07044206