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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05203666

Acronym

LOBSTER

Enrollment

Registered

2022-01-24

Start date

2021-01-01

Completion date

2021-10-21

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Lumbar Spinal Stenosis, Neurologic Intermittent Claudication

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.

Interventions

OTHERpercutaneous removable interspinous process

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Oswestry Disability Index	Baseline	Disability level evaluated with Oswestry Disability Index before intervention

Secondary

Measure	Time frame	Description
Visual Analog Scale for pain	Baseline	Pain level from 0 (no pain) to 100 (unbearable pain) before intervention
Variation of foraminal area	Baseline	Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026