The purpose of this study is to assess the safety and the efficacy of an hydrogel (double cross-link microgel - DXM) injection into the intervertebral disc (IVD) space in patients with painful lumbar degenerative disc disease (DDD) over 24 to 48 weeks.
After being informed of the study and the potential risks, all patients matching the eligibility criteria and who have given their written consent will undergo a gel injection at day 0 after a period of screening of up to 14 days. Then, they will be followed-up for a variable period according to the cohort : * first cohort of 5 patients with only one disc to be treated will be followed during 48 weeks, * second cohort of 5 patients with 2 discs to be treated will be followed during 36 weeks, * third cohort of 10 patients with 1 or 2 discs to be treated will be followed during 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
DXM hydrogel is a pH responsive Double Cross-Linked microgel based on single internally cross-linked microspheres (comprising a methacrylic acid-methyl methacrylate-ethylene glycol dimethacrylate copolymer) The DXM gel is injected into the intervertebral disc (IVD) space via a standardised procedure similar to the routinely-performed Discography procedure. The disc approach described in the discography procedure has been reported to allow the injection of a solution in the centre of the disc. The injection of the gel takes about 2 min.
Polyclinique Bordeaux Nord Aquitaine Centre Vertebra
Bordeaux, France
RECRUITINGThe number of patients with at least one adverse event (AE) or serious adverse event (SAE)
An adverse event (AE) is any untoward medical occurrence in a patient exposed to a medical device and which does not necessarily have a causal relationship with this medical device. An AE can therefore be any unintended disease or injury or clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not considered related to the investigational medical device. A serious adverse event (SAE) is defined as an AE that: * led to a death, injury or permanent impairment to a body structure or a body function; * led to a serious deterioration in health of the subject, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient hospitalization or prolongation of existing hospitalization, or in medical or surgical intervention to prevent life threatening illness * led to foetal distress, foetal death or a congenital abnormality or birth defect.
Time frame: Between screening visit and 24 weeks (measured at each visits)
The number of adverse events (AEs) or serious adverse event (SAEs)
An adverse event (AE) is any untoward medical occurrence in a patient exposed to a medical device and which does not necessarily have a causal relationship with this medical device. An AE can therefore be any unintended disease or injury or clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not considered related to the investigational medical device. A serious adverse event (SAE) is defined as an AE that: * led to a death, injury or permanent impairment to a body structure or a body function; * led to a serious deterioration in health of the subject, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient hospitalization or prolongation of existing hospitalization, or in medical or surgical intervention to prevent life threatening illness * led to foetal distress, foetal death or a congenital abnormality or birth defect.
Time frame: Between screening visit and 24 weeks (measured at each visits)
The number of patients with neurological changes during the follow-up period according to the evaluation of nerve root pain, sensory deficit and motor deficit
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The neurological evaluation will look more specifically for: * The presence or absence of nerve root pain and its localisation (i.e. Lassegue test) * The presence of deferred pain in the leg without deficit * The presence or absence of sensory deficit and its localisation * The presence or absence of motor deficit and its classification from grade 1 to 5 (0 - Total Paralysis, 1 - Palpable or Visible, 2 - Active Movement, gravity eliminated, 3 - Active Movement, against gravity, Contraction, 4 - Active Movement, against some resistance, 5 - Active Movement, against full resistance (normal muscular force))
Time frame: Between screening visit and 24 weeks (measured at each visits)
The change of the water content of the nucleus measured in milliseconds on the MRI during the follow-up period
The Magnetic resonance imaging (MRI) will allow the observation.
Time frame: Between screening visit and 24 weeks (measured at each visits)
The modifications observed after the injection in the adjacent tissues of the injected nucleus
The Magnetic resonance imaging (MRI) will allow the observation of the corresponding adjacent tissues: * Annulus fibrosus * Endplates * Facets
Time frame: Between screening visit and 24 weeks (measured at each visits)
The change of the intervertebral height in millimetres of the injected disc
The Magnetic resonance imaging (MRI) will allow the observation.
Time frame: Between screening visit and 24 weeks (measured at each visits)
The change of the DXM gel position in relation to posterior and anterior limit of the annulus fibrosus and vertebral disc end-plates
The Magnetic resonance imaging (MRI) will allow the observation.
Time frame: Between screening visit and 24 weeks (measured at each visits)
The number of patients with at least one adverse event (AE) or serious adverse event (SAE)
An adverse event (AE) is any untoward medical occurrence in a patient exposed to a medical device and which does not necessarily have a causal relationship with this medical device. An AE can therefore be any unintended disease or injury or clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not considered related to the investigational medical device. A serious adverse event (SAE) is defined as an AE that: * led to a death, injury or permanent impairment to a body structure or a body function; * led to a serious deterioration in health of the subject, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient hospitalization or prolongation of existing hospitalization, or in medical or surgical intervention to prevent life threatening illness * led to foetal distress, foetal death or a congenital abnormality or birth defect.
Time frame: Over 48 weeks for the first cohort (1L) / 36 weeks for the second cohort (2L) / 24 weeks for the third cohort (1-2L)
The number of adverse events (AEs) or serious adverse event (SAEs)
An adverse event (AE) is any untoward medical occurrence in a patient exposed to a medical device and which does not necessarily have a causal relationship with this medical device. An AE can therefore be any unintended disease or injury or clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not considered related to the investigational medical device. A serious adverse event (SAE) is defined as an AE that: * led to a death, injury or permanent impairment to a body structure or a body function; * led to a serious deterioration in health of the subject, that either resulted in: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient hospitalization or prolongation of existing hospitalization, or in medical or surgical intervention to prevent life threatening illness * led to foetal distress, foetal death or a congenital abnormality or birth defect.
Time frame: Over 48 weeks for the first cohort (1L) / 36 weeks for the second cohort (2L) / 24 weeks for the third cohort (1-2L)
The number of patients with neurological changes during the follow-up period according to the evaluation of nerve root pain, sensory deficit and motor deficit
The neurological evaluation will look more specifically for: * The presence or absence of nerve root pain and its localisation (i.e. Lassegue test) * The presence of deferred pain in the leg without deficit * The presence or absence of sensory deficit and its localisation * The presence or absence of motor deficit and its classification from grade 1 to 5 (0 - Total Paralysis, 1 - Palpable or Visible, 2 - Active Movement, gravity eliminated, 3 - Active Movement, against gravity, Contraction, 4 - Active Movement, against some resistance, 5 - Active Movement, against full resistance (normal muscular force))
Time frame: Over 48 weeks for the first cohort (1L) / 36 weeks for the second cohort (2L) / 24 weeks for the third cohort (1-2L)
The change of the water content of the nucleus measured in milliseconds on the MRI during the follow-up period
The Magnetic resonance imaging (MRI) will allow the observation.
Time frame: Over 48 weeks for the first cohort (1L) / 36 weeks for the second cohort (2L) / 24 weeks for the third cohort (1-2L)
The modifications observed after the injection in the adjacent tissues of the injected nucleus
The Magnetic resonance imaging (MRI) will allow the observation of the corresponding adjacent tissues: * Annulus fibrosus * Endplates * Facets
Time frame: Over 48 weeks for the first cohort (1L) / 36 weeks for the second cohort (2L) / 24 weeks for the third cohort (1-2L)
The change of the intervertebral height in millimetres of the injected disc
The Magnetic resonance imaging (MRI) will allow the observation.
Time frame: Over 48 weeks for the first cohort (1L) / 36 weeks for the second cohort (2L) / 24 weeks for the third cohort (1-2L)
The change of the DXM gel position in relation to posterior and anterior limit of the annulus fibrosus and vertebral disc end-plates
The Magnetic resonance imaging (MRI) will allow the observation.
Time frame: Over 48 weeks for the first cohort (1L) / 36 weeks for the second cohort (2L) / 24 weeks for the third cohort (1-2L)
Oswestry disability index (ODI)
The ODI score is based on a self-completed questionnaire of 10 items to measure a patient's permanent functional disability. It is a well-recognised, gold standard orthopaedic score devised in 1980 and which still remains the best and most reliable measure of the overall impact of spinal disease associated with low back pain and any interventions patients may receive. It has been repeatedly used for natural history studies, cohort studies, and for many device and surgery interventions. It is reproducible, reliable and responsive to therapeutic interventions.
Time frame: Measured and compared to baseline at the different time points of the flowchart according to the cohort (over 24 to 48 weeks)
Visual analogue scale (VAS) self-assessment
The visual analogue self-assessment scale is an evaluation performed by the patient to specify his level of pain on a scale of 'no pain' to 'extreme pain'. During the site visit, the VAS is to be filled on-site by the patient and collected by the site staff.
Time frame: Measured and compared to baseline at the different time points of the flowchart according to the cohort (over 24 to 48 weeks)
Working status
The working status will be collected by interviewing the patient about his/her work activity.
Time frame: measured and compared to baseline at the different time points of the flowchart according to the cohort (over 24 to 48 weeks)