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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-10-21

Brief Summary

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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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Detailed Description

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Conditions

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Degenerative Lumbar Spinal Stenosis Neurologic Intermittent Claudication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

percutaneous removable interspinous process

Intervention Type OTHER

percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis.

Interventions

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percutaneous removable interspinous process

percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No