Comparing two bioactive bone substitutes to help spinal fusion after anterior lumbar surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial enrolls adults with degenerative lumbar disc disease who are scheduled for anterior lumbar interbody arthrodesis and compares two osteoinductive bioactive bone substitutes placed inside the interbody implant. Participants receive one of the two bone substitute putties at the time of surgery and are followed with clinical assessments and imaging to document fusion, pain, and disability. Primary outcomes include radiographic fusion rates and clinical measures such as Oswestry Disability Index and pain scores, with monitoring for nonunion and reoperation. The trial is single-center at CHU de Montpellier and excludes patients with conditions that impair bone healing or contraindicate the products.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Montpellier
  Montpellier, France, France Recruiting

Study contacts

• Study coordinator: Nicolas LONJON, MD, PhD
• Email: n-lonjon@chu-montpellier.fr
• Phone: +33467337488

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.