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

Completed

• Conditions: Degenerative Lumbar Spinal Stenosis; Neurologic Intermittent Claudication
• Interventions: Other: percutaneous removable interspinous process

• Registration Number: NCT05203666
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-10-21
• Status Verified: 2021-12
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-21
• Last Update Submitted: 2022-01-21
• Study First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	3 Months	Disability level evaluated with Oswestry Disability Index after intervention

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale for pain	3 Months	Pain level from 0 (no pain) to 100 (unbearable pain) after intervention
Variation of foraminal area	3 Months	Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France