Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease (NCT04727385) | Clinical Trial Compass
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Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
France20 participantsStarted 2020-09-15
Plain-language 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 degenerative disc disease (DDD) over 24 to 48 weeks.
Who can participate
Age range18 Years – 55 Years
SexALL
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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
✓. 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
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.
✕
What they're measuring
1
The number of patients with at least one adverse event (AE) or serious adverse event (SAE)
Timeframe: Between screening visit and 24 weeks (measured at each visits)
2
The number of adverse events (AEs) or serious adverse event (SAEs)
Timeframe: Between screening visit and 24 weeks (measured at each visits)
3
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
Timeframe: Between screening visit and 24 weeks (measured at each visits)
4
The change of the water content of the nucleus measured in milliseconds on the MRI during the follow-up period
Timeframe: Between screening visit and 24 weeks (measured at each visits)
5
The modifications observed after the injection in the adjacent tissues of the injected nucleus
Timeframe: Between screening visit and 24 weeks (measured at each visits)
6
The change of the intervertebral height in millimetres of the injected disc
Timeframe: Between screening visit and 24 weeks (measured at each visits)
7
The change of the DXM gel position in relation to posterior and anterior limit of the annulus fibrosus and vertebral disc end-plates