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

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 Overview

• Status: Completed
• Conditions: Lumbar Spine Instability
• Intervention / Treatment: Device: Magnetic Resonance Imaging

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Dinh Qui Du PHAN, MD, CHU Brugmann; Principal Investigator: Tamas ILLES, MD, CHU Brugmann

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 16, 2024
• Study Completion (Actual): June 16, 2024

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimated): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: intervertebral disc; glycosaminoglycans; MRI T2 weighted
• Other Study ID Numbers: CHUB-DGemric

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No