Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal St… (NCT05587465) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
Italy210 participantsStarted 2022-10-05
Plain-language summary
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female subjects ≥ 45 years of age.
✓. Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart).
✓. Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months.
✓. Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal).
✓. Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, or foraminal spinal canal at one or two contiguous levels from L1-L5. Moderate spinal stenosis is defined as 25% to 50% reduction in lateral/central foramen compared to the adjacent levels, with radiographic confirmation of any one of the following:
✓. Evidence of thecal sac and/or cauda equina compression.
✓. Evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.
✓. Evidence of hypertrophic facets with canal encroachment.
Exclusion criteria
✕. Axial back pain only.
✕. Fixed motor deficit.
✕. Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or investigational device.
What they're measuring
1
Effectiveness of the Lobster device in comparison to an SSED-based performance goal (PG)
Timeframe: 12 months
2
Safety of the Lobster device in comparison to an SSED-based performance goal (PG)