Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis (NCT05961956) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
Luxembourg5 participantsStarted 2023-10-12
Plain-language summary
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged ≥18 years to ≤80 years.
✓. Patient diagnosed with symptomatic DLS with confirmed:
✓. Classification: Meyerding grade I or II DLS
✓. One vertebral segment within the lumbar region from L1-S1
✓. Availability of AP and LAT X-ray, MRI and/or CT scan at which the diagnosis was made.
✓. The estimated volume of targeted disc space to be filled (both inside and around the interbody cage) should not exceed 10cc.
✓. Clinically meaningful pain or neurological symptoms with or without claudication confirmed by a preoperative ODI score \>30, which have been unresponsive to a minimum of 3 consecutive months of structured conservative medical management (including at least pain medication, activity modification, and daily exercise).
✓. Patient is eligible for surgery by minimally invasive or open transforaminal lumbar interbody fusion (TLIF)3.
Exclusion criteria
✕. History of previously attempted spinal fusion at the same vertebral level, or at a level immediately adjacent to the level intended to undergo the spondylodesis. Decompressive surgery alone (laminectomy) is not an exclusion criterion.
✕. Patient with a BMI of ≥35.
✕. Presence of clinically significant infection at the target implant site or presence of any systemic infection.