MRI Analysis of Glycosaminoglycan Modifications Inside the Intervertebral Disk After Distraction and Posterior Fusion

Overview

Degenerative disc disease (DDD) is the primary cause of low back pain. The most important factor in the development of DDD is the vertical load force on the disc, increasing the hydrostatic pressure and facilitating discs degenerations. One of the most common conditions accompanying DDD is segmental instability of the spine. The pathogenesis evolves in three phases characterized by a progressive disc dehydration and loss of the disc height. This phenomenon can be observed in magnetic resonance imaging (T2 weighted MRI) as a decrease of the water signal inside the intervertebral disc. It is considered as an indirect sign of the alteration of the composition (including glycosaminoglycans) and the structure of the intervertebral disk with, as consequence, a modification of the spine biomechanics. Animal studies showed that disc regeneration could be enhanced by a decrease of the hydrostatic pressure. This could be observed as a signal increase on T2 weighted MRI. Recent quantitative MRI sequences now allow the quantification of glycosaminoglycans (GAG) concentration inside the cartilage and in the intervertebral disc. The actual surgical trends are in favor of an anterior (intersomatic) vertebrak fusion, associated or not with a posterior fusion. These technics sacrifice the intervertebral disc and change the spine biomechanics. Based on a pilot study, the investigators believe that the conservation and even a regeneration of the intervertebral disc is possible and allows the preservation of the spine biomechanics. The purpose of the study is to analyze the relations between specific MRI signals, the GAGs concentration, and the functional outcome before and after the surgical treatment.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2024

Interventions

  • Device: Magnetic Resonance Imaging
    • Specific MRI sequences (delayed gadolinium-enhanced magnetic resonance imaging of cartilage -dGEMRIC) performed before the surgery, 6 months and 1 year after surgery will allow to measure the following parameters: disc height, total lumbar spine lenght, GAGs concentration.

Arms, Groups and Cohorts

  • Experimental: lumbar spine segmental instability
    • Patients with a segmental instability of the lumbar spine having undergone surgery. Lumbar spine instability diagnosis is based on imaging (Magnetic resonance imaging, standard radiography, and EOS imaging). Surgical treatment is indicated if the pain is relieved by wearing a brace during at least three months.

Clinical Trial Outcome Measures

Primary Measures

  • Gycosaminoglycan (GAG) concentration of the intervertebral disk
    • Time Frame: Baseline: before surgery
    • GAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
  • Gycosaminoglycan (GAG) concentration of the intervertebral disk
    • Time Frame: Six months after surgery
    • GAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
  • Gycosaminoglycan (GAG) concentration of the intervertebral disk
    • Time Frame: 1 year after surgery
    • GAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique

Secondary Measures

  • Disc height
    • Time Frame: Baseline: before surgery
    • Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
  • Disc height
    • Time Frame: Six months after surgery
    • Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
  • Disc height
    • Time Frame: 1 year after surgery
    • Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
  • Total lumbar spine length
    • Time Frame: Baseline: before surgery
    • Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
  • Total lumbar spine length
    • Time Frame: Six months after surgery
    • Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
  • Total lumbar spine length
    • Time Frame: 1 year after surgery
    • Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
  • Lumbar lordosis angle
    • Time Frame: Baseline: before surgery
    • Will be measured by the EOS imaging system.
  • Lumbar lordosis angle
    • Time Frame: Six months after surgery
    • Will be measured by the EOS imaging system.
  • Lumbar lordosis angle
    • Time Frame: 1 year after surgery
    • Will be measured by the EOS imaging system.
  • Oswestry Disability Index (ODI)
    • Time Frame: Baseline: before surgery
    • Estimation of the functional state of the patient by the Oswestry Disability questionnaire.
  • Oswestry Disability Index (ODI)
    • Time Frame: Six months after surgery
    • Estimation of the functional state of the patient by the Oswestry Disability questionnaire.
  • Oswestry Disability Index (ODI)
    • Time Frame: 1 year after surgery
    • Estimation of the functional state of the patient by the Oswestry Disability questionnaire.
  • SF-36
    • Time Frame: Baseline: before surgery
    • Estimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.
  • SF-36
    • Time Frame: Six months after surgery
    • Estimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.
  • SF-36
    • Time Frame: 1 year after surgery
    • Estimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.

Participating in This Clinical Trial

Inclusion Criteria

  • Patient with segmental instability of the lumbar spine – Patient with planned surgery Exclusion Criteria:

  • clinical and iconographic signs of neurological compression – intervertebral disc completely degenerated – infection – spondylolisthesis (superior to grade I) – fracture – neoplasia.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brugmann University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tamas Illes, Head of clinic – Brugmann University Hospital
  • Overall Official(s)
    • Tamas Illes, MD, Principal Investigator, CHU Brugmann
    • Dinh Qui Du PHAN, MD, Principal Investigator, CHU Brugmann

References

Manchikanti L, Singh V, Datta S, Cohen SP, Hirsch JA; American Society of Interventional Pain Physicians. Comprehensive review of epidemiology, scope, and impact of spinal pain. Pain Physician. 2009 Jul-Aug;12(4):E35-70.

Iatridis JC, MacLean JJ, Roughley PJ, Alini M. Effects of mechanical loading on intervertebral disc metabolism in vivo. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2(0 2):41-6. doi: 10.2106/JBJS.E.01407.

Haughton V. The "Dehydrated" Lumbar Intervertebral Disk on MR, its Anatomy, Biochemistry and Biomechanics. Neuroradiol J. 2011 Aug 31;24(4):564-9. doi: 10.1177/197140091102400412. Epub 2011 Sep 2.

Kroeber M, Unglaub F, Guehring T, Nerlich A, Hadi T, Lotz J, Carstens C. Effects of controlled dynamic disc distraction on degenerated intervertebral discs: an in vivo study on the rabbit lumbar spine model. Spine (Phila Pa 1976). 2005 Jan 15;30(2):181-7. doi: 10.1097/01.brs.0000150487.17562.b1. Erratum In: Spine. 2005 Mar 15;30(6):710. Guegring, Thorsten [corrected to Guehring, Thorsten].

Gray ML. Toward imaging biomarkers for glycosaminoglycans. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1(Suppl 1):44-9. doi: 10.2106/JBJS.H.01498.

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