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

Degenerative Lumbar Spinal Stenosis Clinical Trial

— LOBSTER  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05203666
• Other study ID #: 21Imagerie03
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: October 21, 2021

Study information

• Verified date: December 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 21, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Lumbar Spinal Stenosis
• Intermittent Claudication
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	Disability level evaluated with Oswestry Disability Index before intervention	Baseline
Primary	Oswestry Disability Index	Disability level evaluated with Oswestry Disability Index after intervention	3 Months
Secondary	Visual Analog Scale for pain	Pain level from 0 (no pain) to 100 (unbearable pain) before intervention	Baseline
Secondary	Visual Analog Scale for pain	Pain level from 0 (no pain) to 100 (unbearable pain) after intervention	3 Months
Secondary	Variation of foraminal area	Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan	Baseline
Secondary	Variation of foraminal area	Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan	3 Months