Intervertebral DXM Gel Injection in Adults With Painful L... | NCT04727385

Name	Class
Excelya	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single-arm of 3 cohorts	Experimental	These patients will be sequentially recruited in 3 cohorts : One disc level cohort: 5 patients with only one disc to be treated; First enrolled cohort with 48 weeks of follow-up (9 visits V1-V9) Two disc level cohort: 5 patients with 2 discs to be treated; Second enrolled cohort with 36 weeks of follow-up (8 visits, same visits except for V9) One or two disc level cohort: 10 patients with 1 or 2 discs to be treated; Third enrolled cohort with 24 weeks of follow-up (6 visits, V1 to 7 except for V4)	Device: Double Crosslink Microgel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Double Crosslink Microgel	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patient aged between 18 and 55 (inclusive)
Discogenic low back pain, confirmed by a history of Low Back Pain, with a minimum of 3 months of continuous pain or 6 months of acute episodes of pain despite the conservative treatment including painkillers and physiotherapy
Oswestry Disability Index (ODI) ≥ 30% and ≤ 60%,
Painful disc(s) between L1 and S1 represented
1. For cohort 1L: at a single disc level
2. For cohort 2L: at 2 disc levels
3. For cohort 1-2L: at 1 or 2 disc levels
Patients with a Zung depression score ≤ 49, Note: Patients with a Zung depression score between ≥ 50 and ≤ 64 may be included if deemed suitable for trial inclusion by the investigator
Partial dehydration (grey disc) confirmed by MRI, grade II/III Pfirrmann classification

Note:
- Pfirrmann Grade I lesions are not contra-indications to recruitment, but can never be the target of any intervention in this trial. Patients featuring grade I disc(s) in conjunction with a grade II/III meet the inclusion criteria for his(her) disc Grade II/III disc to be treated
- Pfirrmann Grade IV and V disc lesions are absolute contra-indications for inclusion
Female patients of childbearing potential must have a negative urine pregnancy test at screening and use an effective birth control during the follow up period after the injection procedure
Patients who are willing and capable of understanding the investigator's explanations, following his instructions and adhering to the follow-up visits according to the study protocol, including a willingness and ability to undergo MRI scanning,
Patient giving informed consent to take part in the study

Exclusion Criteria:

Averted nerve root pain and potential root compression Note: Referred leg pain authorised
Presence of posterior bone spurs (osteophytes)
Partial or total Modic signal grade 1 at the considered disc level
Patients with active systemic infection or infection localized to the site of the proposed implantation.
Any conditions not described in the indications for use.
Any mental conditions or neuromuscular disease that may generate an unacceptable risk of failure or postoperative complication.
Patients with existing disc herniation at the considered level and on adjacent discs
Endplate disease, defect or weakness, e.g. Schmorl nodule
Vertebral bone abnormalities with active angioma
Disc collapse ≥ 15% when disc height is compared to the height of the upper adjacent disc
One lumbar disc rated grade IV or V on the Pfirrmann classification
Imaging showing facet arthrosis
Lytic spondylolisthesis
Degenerative spondylolisthesis grade > grade I Meyerding
Congenital or idiopathic deformities of the spine (e.g. Scoliosis >20° Cobb or Kyphosis)
Old or acute vertebral fractures in the lumbar spine
Patients with any prior spine procedure in the lumbar spine
Any skin disease or inadequate tissue coverage at the site of the injection
Any medical or surgical conditions that could preclude the potential benefit of disc injection must be carefully analysed before the procedure, such as congenital abnormalities, immunosuppressive disease, elevation of erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) concentration not explained by other diseases, elevation of white blood cell (WBC) count, or marked left shift in the WBC differential count, should be carefully taken into consideration prior to the surgical procedure.

Note: These contra-indications can be relative or absolute and must be taken into account by the physician when making his decision. The above list is not exhaustive.
Tumours with any metastatic potential, or known metastases, in any part of the body
Known infection with HIV or Hepatitis B, C or E
Patient that has received or is seeking employee compensation
Zung depression score ≥ 65
Substance abuse or dependency (pharmaceuticals, drugs, alcohol)
Disabling obesity (BMI > 35kg/m²)
History of chemical dependency (e.g. illicit drugs, or opiates) or significant emotional or psychosocial disturbance which may have an effect on treatment outcome
Patients who are pregnant, breast feeding or planning pregnancy during the study
Anticoagulation (beyond low level prophylactic doses of single anti-platelet agents)
Inability to undertake or known contra-indications to MRI scanning
Known hypersensitivity to barium sulphate

ID	Term
D055959	Intervertebral Disc Degeneration
C535531	Intervertebral disc disease

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases