Status:
UNKNOWN
Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
Lead Sponsor:
Gelmetix
Collaborating Sponsors:
Excelya
Conditions:
Degenerative Disc Disease
Chronic Lower Back Pain
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- For cohort 1L: at a single disc level
- For cohort 2L: at 2 disc levels
- 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
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04727385
Start Date
September 15 2020
End Date
October 1 2021
Last Update
January 27 2021
Active Locations (1)
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1
Polyclinique Bordeaux Nord Aquitaine Centre Vertebra
Bordeaux, France, 33300