Clinical trial NCT05203666: Clinical and Radiological Outcomes Following Insertion of a Novel Removable Percutaneous Interspinous Process Spacer: an Initial Experience.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Lumbar Spinal Stenosis
Neurologic Intermittent Claudication
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: Baseline
measure: Oswestry Disability Index
timeFrame: 3 Months
Secondary outcomes:
measure: Visual Analog Scale for pain
timeFrame: Baseline
measure: Visual Analog Scale for pain
timeFrame: 3 Months
measure: Variation of foraminal area
timeFrame: Baseline
measure: Variation of foraminal area
timeFrame: 3 Months
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
citation: 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.