Degenerative Lumbar Spinal StenosisLOBSTERNCT05203666
Clinical and Radiological Outcomes Following Insertion of a Novel Removable Percutaneous Interspinous Process Spacer: an Initial Experience.
An observational study of Degenerative Lumbar Spinal Stenosis and Neurologic Intermittent Claudication, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis, Neurologic Intermittent Claudication
- What is being tested?
- percutaneous removable interspinous process
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 21 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- removable percutaneous IPS treatment
- attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- percutaneous removable interspinous process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous removable interspinous processOther
percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: percutaneous removable interspinous process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Disability level evaluated with Oswestry Disability Index before intervention
Measured: Baseline
Oswestry Disability Index
Disability level evaluated with Oswestry Disability Index after intervention
Measured: 3 Months
Secondary outcomes (4)
Visual Analog Scale for pain
Pain level from 0 (no pain) to 100 (unbearable pain) before intervention
Measured: Baseline
Visual Analog Scale for pain
Pain level from 0 (no pain) to 100 (unbearable pain) after intervention
Measured: 3 Months
Variation of foraminal area
Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan
Measured: Baseline
Variation of foraminal area
Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203666
- Sponsor's protocol ID
- 21Imagerie03
- Acronym
- LOBSTER
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavan LJ, Dalili D, De Vivo AE, Hamel-Senecal A, Torre F, Rudel A, Manfre L, Amoretti N. Clinical and radiological outcomes following insertion of a novel removable percutaneous interspinous process spacer: an initial experience. Neuroradiology. 2022 Sep;64(9):1887-1895. doi: 10.1007/s00234-022-02977-y. Epub 2022 May 31.
PubMed 35641830
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05203666
- Acronym / sponsor ID
- LOBSTER / 21Imagerie03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| degenerative lumbar spinal stenosis | – | Other: percutaneous removable interspinous processAll patients treated in 2019 with a percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- removable percutaneous IPS treatment
- attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous removable interspinous processpercutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis. | Other | degenerative lumbar spinal stenosis |
Primary outcome
Oswestry Disability Index
Time frame: Baseline
Disability level evaluated with Oswestry Disability Index before intervention
Oswestry Disability Index
Time frame: 3 Months
Disability level evaluated with Oswestry Disability Index after intervention
4 secondary outcomes
Visual Analog Scale for pain
Time frame: Baseline
Visual Analog Scale for pain
Time frame: 3 Months
Variation of foraminal area
Time frame: Baseline
Variation of foraminal area
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 35641830Pavan LJ, Dalili D, De Vivo AE, Hamel-Senecal A, Torre F, Rudel A, Manfre L, Amoretti N. Clinical and radiological outcomes following insertion of a novel removable percutaneous interspinous process spacer: an initial experience. Neuroradiology. 2022 Sep;64(9):1887-1895. doi: 10.1007/s00234-022-02977-y. Epub 2022 May 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spinal Stenosis and Neurologic Intermittent Claudication, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05203666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.