Clinical trial NCT02815696: MRI Analysis of Glycosaminoglycan Modifications Inside the Intervertebral Disk After Distraction and Posterior Fusion
Official title: MRI Analysis of Glycosaminoglycan Modifications Inside the Intervertebral Disk After Distraction and Posterior Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Instability
Keywords: MRI T2 weighted
intervertebral disc
glycosaminoglycans
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gycosaminoglycan (GAG) concentration of the intervertebral disk
timeFrame: Baseline: before surgery
measure: Gycosaminoglycan (GAG) concentration of the intervertebral disk
timeFrame: Six months after surgery
measure: Gycosaminoglycan (GAG) concentration of the intervertebral disk
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Disc height
timeFrame: Baseline: before surgery
measure: Disc height
timeFrame: Six months after surgery
measure: Disc height
timeFrame: 1 year after surgery
measure: Total lumbar spine length
timeFrame: Baseline: before surgery
measure: Total lumbar spine length
timeFrame: Six months after surgery
measure: Total lumbar spine length
timeFrame: 1 year after surgery
measure: Lumbar lordosis angle
timeFrame: Baseline: before surgery
measure: Lumbar lordosis angle
timeFrame: Six months after surgery
measure: Lumbar lordosis angle
timeFrame: 1 year after surgery
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline: before surgery
measure: Oswestry Disability Index (ODI)
timeFrame: Six months after surgery
measure: Oswestry Disability Index (ODI)
timeFrame: 1 year after surgery
measure: SF-36
timeFrame: Baseline: before surgery
measure: SF-36
timeFrame: Six months after surgery
measure: SF-36
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Tamas Illes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Dinh Qui Du PHAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.