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NCT Number: NCT02815696

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.

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Key information

Conditions

Lumbar Spine Instability

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance Imaging

Device

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.

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Disc height

    Time frame: Baseline: before surgery

    Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique

  2. Disc height

    Time frame: Six months after surgery

    Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique

  3. Disc height

    Time frame: 1 year after surgery

    Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique

  4. Total lumbar spine length

    Time frame: Baseline: before surgery

    Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique

  5. 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

  6. 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

  7. Lumbar lordosis angle

    Time frame: Baseline: before surgery

    Will be measured by the EOS imaging system.

  8. Lumbar lordosis angle

    Time frame: Six months after surgery

    Will be measured by the EOS imaging system.

  9. Lumbar lordosis angle

    Time frame: 1 year after surgery

    Will be measured by the EOS imaging system.

  10. Oswestry Disability Index (ODI)

    Time frame: Baseline: before surgery

    Estimation of the functional state of the patient by the Oswestry Disability questionnaire.

  11. Oswestry Disability Index (ODI)

    Time frame: Six months after surgery

    Estimation of the functional state of the patient by the Oswestry Disability questionnaire.

  12. Oswestry Disability Index (ODI)

    Time frame: 1 year after surgery

    Estimation of the functional state of the patient by the Oswestry Disability questionnaire.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2016
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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