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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lumbar Spine Instability

Intervention / Treatment
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* Device: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lumbar spine segmental instability<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI T2 weighted, intervertebral disc, glycosaminoglycans