Lumbar Spine InstabilityNCT02815696
MRI Analysis of Glycosaminoglycan Modifications Inside the Intervertebral Disk After Distraction and Posterior Fusion
A study testing Magnetic Resonance Imaging in people with Lumbar Spine Instability, run by Brugmann University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Spine Instability
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2016to 16 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with segmental instability of the lumbar spine
- Patient with planned surgery
Who cannot join
- clinical and iconographic signs of neurological compression
- intervertebral disc completely degenerated
- infection
- spondylolisthesis (superior to grade I)
- fracture
- neoplasia.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Lumbar Spine Instability
- Being tested
- Magnetic Resonance Imaging
- Keywords
- MRI T2 weighted, intervertebral disc, glycosaminoglycans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gycosaminoglycan (GAG) concentration of the intervertebral disk
GAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Measured: 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
Measured: 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
Measured: 1 year after surgery
Secondary outcomes (15)
Disc height
Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Measured: Baseline: before surgery
Disc height
Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Measured: Six months after surgery
Disc height
Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Measured: 1 year after surgery
Total lumbar spine length
Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Measured: Baseline: before surgery
Total lumbar spine length
Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Measured: Six months after surgery
Total lumbar spine length
Will be measured using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Measured: 1 year after surgery
Lumbar lordosis angle
Will be measured by the EOS imaging system.
Measured: Baseline: before surgery
Lumbar lordosis angle
Will be measured by the EOS imaging system.
Measured: Six months after surgery
Lumbar lordosis angle
Will be measured by the EOS imaging system.
Measured: 1 year after surgery
Oswestry Disability Index (ODI)
Estimation of the functional state of the patient by the Oswestry Disability questionnaire.
Measured: Baseline: before surgery
Oswestry Disability Index (ODI)
Estimation of the functional state of the patient by the Oswestry Disability questionnaire.
Measured: Six months after surgery
Oswestry Disability Index (ODI)
Estimation of the functional state of the patient by the Oswestry Disability questionnaire.
Measured: 1 year after surgery
SF-36
Estimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.
Measured: Baseline: before surgery
SF-36
Estimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.
Measured: Six months after surgery
SF-36
Estimation of the functional state of the patient by the SF-36 questionnaire relative to the quality of life.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start1 Jul 2016
- Primary completion16 Jun 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Illes, Brugmann University Hospital
- Investigators
- Tamas Illes, MD, Principal investigator, CHU BrugmannDinh Qui Du PHAN, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815696
- Sponsor's protocol ID
- CHUB-DGemric
- Status last verified
- Feb 2025
- First submitted
- 24 Jun 2016
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19668291Iatridis 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.
PubMed 16595442Haughton 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.
PubMed 24059714Kroeber 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.
PubMed 15644753Gray 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.
PubMed 19182023
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Analysis of Glycosaminoglycan Modifications Inside the Intervertebral Disk After Distraction and Posterior Fusion
- ClinicalTrials.gov ID
- NCT02815696
- Acronym / sponsor ID
- CHUB-DGemric
- Conditions
- Lumbar Spine Instability
- Keywords
- MRI T2 weighted, intervertebral disc, glycosaminoglycans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lumbar spine segmental instability | Experimental | Device: Magnetic Resonance ImagingPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with segmental instability of the lumbar spine
- Patient with planned surgery
Key exclusion criteria (6 listed)
- clinical and iconographic signs of neurological compression
- intervertebral disc completely degenerated
- infection
- spondylolisthesis (superior to grade I)
- fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingSpecific 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. | Device | lumbar spine segmental instability |
Primary outcome
Gycosaminoglycan (GAG) concentration of the intervertebral disk
Time frame: Baseline: before surgery
GAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Gycosaminoglycan (GAG) concentration of the intervertebral disk
Time frame: Six months after surgery
GAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
Gycosaminoglycan (GAG) concentration of the intervertebral disk
Time frame: 1 year after surgery
GAG concentration is estimated using the delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) technique
15 secondary outcomes
Disc height
Time frame: Baseline: before surgery
Disc height
Time frame: Six months after surgery
Disc height
Time frame: 1 year after surgery
Total lumbar spine length
Time frame: Baseline: before surgery
Total lumbar spine length
Time frame: Six months after surgery
Total lumbar spine length
Time frame: 1 year after surgery
Lumbar lordosis angle
Time frame: Baseline: before surgery
Lumbar lordosis angle
Time frame: Six months after surgery
Lumbar lordosis angle
Time frame: 1 year after surgery
Oswestry Disability Index (ODI)
Time frame: Baseline: before surgery
Oswestry Disability Index (ODI)
Time frame: Six months after surgery
Oswestry Disability Index (ODI)
Time frame: 1 year after surgery
SF-36
Time frame: Baseline: before surgery
SF-36
Time frame: Six months after surgery
SF-36
Time frame: 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 19668291Manchikanti 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.
- Background: PubMed 16595442Iatridis 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.
- Background: PubMed 24059714Haughton 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.
- Background: PubMed 15644753Kroeber 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.
- Background: PubMed 19182023Gray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamas Illes, MD principal investigator
CHU Brugmann
Dinh Qui Du PHAN, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Lumbar Spine Instability, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gycosaminoglycan (GAG) concentration of the intervertebral disk (time frame: Baseline: before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02815696, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.