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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02815696
Enrollment
40
Registered
2016-06-28
Start date
2016-07-01
Completion date
2024-06-16
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spine Instability

Keywords

MRI T2 weighted, intervertebral disc, glycosaminoglycans

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.

Interventions

DEVICEMagnetic 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.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gycosaminoglycan (GAG) concentration of the intervertebral diskBaseline: before surgeryGAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique

Secondary

MeasureTime frameDescription
Disc heightBaseline: before surgeryWill be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Total lumbar spine lengthBaseline: before surgeryWill be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Lumbar lordosis angleBaseline: before surgeryWill be measured by the EOS imaging system.
Oswestry Disability Index (ODI)Baseline: before surgeryEstimation of the functional state of the patient by the Oswestry Disability questionnaire.
SF-36Baseline: before surgeryEstimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026