Clinical and Radiological Outcomes Following Insertion of a Novel Removable Percutaneous Interspinous Process Spacer: an Initial Experience. (LOBSTER)
January 21, 2022 updated by: Centre Hospitalier Universitaire de Nice
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nice, France, 06000
- Nice University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients treated with this removable percutaneous IPS in our two Centres from December 2018 to February 2020 were retrospectively reviewed and those with complete imaging and clinical data were selected.
Patients attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index
Time Frame: Baseline
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Disability level evaluated with Oswestry Disability Index before intervention
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Baseline
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Oswestry Disability Index
Time Frame: 3 Months
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Disability level evaluated with Oswestry Disability Index after intervention
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3 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale for pain
Time Frame: Baseline
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Pain level from 0 (no pain) to 100 (unbearable pain) before intervention
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Baseline
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Visual Analog Scale for pain
Time Frame: 3 Months
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Pain level from 0 (no pain) to 100 (unbearable pain) after intervention
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3 Months
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Variation of foraminal area
Time Frame: Baseline
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Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan
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Baseline
|
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Variation of foraminal area
Time Frame: 3 Months
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Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan
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3 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2021
Primary Completion (ACTUAL)
June 1, 2021
Study Completion (ACTUAL)
October 21, 2021
Study Registration Dates
First Submitted
December 27, 2021
First Submitted That Met QC Criteria
January 21, 2022
First Posted (ACTUAL)
January 24, 2022
Study Record Updates
Last Update Posted (ACTUAL)
January 24, 2022
Last Update Submitted That Met QC Criteria
January 21, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21Imagerie03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.