A Multicentric Retrospective Evaluation of Clinical and Radiologic Outcome of All Patients Treated With a Removable Percutaneous Interspinous Process Spacer (LobsterProject® Techlamed®) for Symptomatic Degenerative Lumbar Spinal Stenosis in 2019.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Sponsor
- Centre Hospitalier Universitaire de Nice
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Oswestry Disability Index
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Purpose To evaluate clinical and radiologic outcome of a series of patients treated with a removable percutaneous interspinous process spacer (IPS) (LobsterProject® Techlamed®) for symptomatic degenerative lumbar spinal stenosis (DLSS).
Methods All patients treated in the two considered Centres with this IPS during 2019 were retrospectively reviewed. Patients with incomplete clinical or radiological documentation were not included. Procedures were performed under deep sedation or general anaesthesia by two interventional radiologists. Patients were clinically evaluated before intervention and at 3-month follow-up with Visual Analog Scale for pain (VAS), Oswestry Disability Index (ODI) and radiologically with MRI or CT scans. Neural foramina were independently measured for each patient on pre- and post-procedural CT scans by two radiologists.
Investigators
Eligibility Criteria
Inclusion Criteria
- •removable percutaneous IPS treatment
- •attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment
Exclusion Criteria
- •PS positioning included cauda equina syndrome
- •permanent motor deficit,
- •previous spine surgery,
- •spondylolisthesis greater than Meyerding grade I,
- •local or systemic infection and severe osteoarthritis with pronounced osteophytosis or bone bridges
Outcomes
Primary Outcomes
Oswestry Disability Index
Time Frame: 3 Months
Disability level evaluated with Oswestry Disability Index after intervention
Secondary Outcomes
- Visual Analog Scale for pain(3 Months)
- Variation of foraminal area(3 Months)