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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02815696
Other study ID # CHUB-DGemric
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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