NCT02815696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2024

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

8 years

First QC Date

June 24, 2016

Last Update Submit

February 5, 2025

Conditions

Lumbar Spine Instability

Keywords

MRI T2 weightedintervertebral discglycosaminoglycans

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (15)

  • Disc height

    Baseline: before surgery

  • Disc height

    Six months after surgery

  • Disc height

    1 year after surgery

  • Total lumbar spine length

    Baseline: before surgery

  • Total lumbar spine length

    Six months after surgery

  • +10 more secondary outcomes

Study Arms (1)

lumbar spine segmental instability

EXPERIMENTAL

Patients with a segmental instability of the lumbar spine having undergone surgery. Lumbar spine instability diagnosis is based on imaging (Magnetic resonance imaging, standard radiography, and EOS imaging). Surgical treatment is indicated if the pain is relieved by wearing a brace during at least three months.

Device: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingDEVICE

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.

lumbar spine segmental instability

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with segmental instability of the lumbar spine
  • Patient with planned surgery

You may not qualify if:

  • clinical and iconographic signs of neurological compression
  • intervertebral disc completely degenerated
  • infection
  • spondylolisthesis (superior to grade I)
  • fracture
  • neoplasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (5)

  • 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.

    PMID: 19668291BACKGROUND

  • 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.

    PMID: 16595442BACKGROUND

  • 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.

    PMID: 24059714BACKGROUND

  • 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.

    PMID: 15644753BACKGROUND

  • 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.

    PMID: 19182023BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Tamas Illes, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

  • Dinh Qui Du PHAN, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 28, 2016

Study Start

July 1, 2016

Primary Completion

June 16, 2024

Study Completion

June 16, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)