MRI Analysis of Glycosaminoglycan Modifications Inside the Intervertebral Disk After Distraction and Posterior Fusion
- Conditions
- Lumbar Spine Instability
- Interventions
- Device: Magnetic Resonance Imaging
- Registration Number
- NCT02815696
- Lead Sponsor
- Brugmann University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Patient with segmental instability of the lumbar spine
- Patient with planned surgery
- clinical and iconographic signs of neurological compression
- intervertebral disc completely degenerated
- infection
- spondylolisthesis (superior to grade I)
- fracture
- neoplasia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lumbar spine segmental instability Magnetic Resonance Imaging 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.
- Primary Outcome Measures
Name Time Method Gycosaminoglycan (GAG) concentration of the intervertebral disk 1 year after surgery GAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
- Secondary Outcome Measures
Name Time Method Oswestry Disability Index (ODI) 1 year after surgery Estimation of the functional state of the patient by the Oswestry Disability questionnaire.
SF-36 1 year after surgery Estimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.
Disc height 1 year after surgery Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Total lumbar spine length 1 year after surgery Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Lumbar lordosis angle 1 year after surgery Will be measured by the EOS imaging system.
Trial Locations
- Locations (1)
CHU Brugmann
🇧🇪Brussels, Belgium