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

Lumbar Spine Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02815696
• Other study ID #: CHUB-DGemric
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Spine Instability

Intervention

Device:
• Magnetic 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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Erratum In: Spine. 2005 Mar 15;30(6):710. Guegring, Thorsten [corrected to Guehring, Thorsten]. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Disc height	Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique	Baseline: before surgery
Secondary	Disc height	Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique	Six months after surgery
Secondary	Disc height	Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique	1 year after surgery
Secondary	Total lumbar spine length	Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique	Baseline: before surgery
Secondary	Total lumbar spine length	Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique	Six months after surgery
Secondary	Total lumbar spine length	Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique	1 year after surgery
Secondary	Lumbar lordosis angle	Will be measured by the EOS imaging system.	Baseline: before surgery
Secondary	Lumbar lordosis angle	Will be measured by the EOS imaging system.	Six months after surgery
Secondary	Lumbar lordosis angle	Will be measured by the EOS imaging system.	1 year after surgery
Secondary	Oswestry Disability Index (ODI)	Estimation of the functional state of the patient by the Oswestry Disability questionnaire.	Baseline: before surgery
Secondary	Oswestry Disability Index (ODI)	Estimation of the functional state of the patient by the Oswestry Disability questionnaire.	Six months after surgery
Secondary	Oswestry Disability Index (ODI)	Estimation of the functional state of the patient by the Oswestry Disability questionnaire.	1 year after surgery
Secondary	SF-36	Estimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.	Baseline: before surgery
Secondary	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
Secondary	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