Clinical and Radiological Outcomes Following Insertion of a Novel Removable Percutaneous Interspinous Process Spacer: an Initial Experience. (LOBSTER)

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Neurologic Intermittent Claudication; Degenerative Lumbar Spinal Stenosis

Treatments: Other: percutaneous removable interspinous process

Study type: Observational

Funder types: Other

Identifiers

NCT05203666

21Imagerie03

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

59 participants in 1 patient group

degenerative lumbar spinal stenosis

Description:

All patients treated in 2019 with a percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis.

Treatment:

Other: percutaneous removable interspinous process