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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| degenerative lumbar spinal stenosis | All patients treated in 2019 with a percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous removable interspinous process | Other | percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | Disability level evaluated with Oswestry Disability Index before intervention | Baseline |
| Oswestry Disability Index | Disability level evaluated with Oswestry Disability Index after intervention | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for pain | Pain level from 0 (no pain) to 100 (unbearable pain) before intervention | Baseline |
| Visual Analog Scale for pain | Pain level from 0 (no pain) to 100 (unbearable pain) after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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All patients treated with this removable percutaneous IPS in our two Centres from December 2018 to February 2020 were retrospectively reviewed and those with complete imaging and clinical data were selected. Patients attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nice University Hospital | Nice | 06000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35641830 | Derived | Pavan LJ, Dalili D, De Vivo AE, Hamel-Senecal A, Torre F, Rudel A, Manfre L, Amoretti N. Clinical and radiological outcomes following insertion of a novel removable percutaneous interspinous process spacer: an initial experience. Neuroradiology. 2022 Sep;64(9):1887-1895. doi: 10.1007/s00234-022-02977-y. Epub 2022 May 31. |
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| 3 Months |
| Variation of foraminal area | Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan | Baseline |
| Variation of foraminal area | Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan | 3 Months |