CompletedNot Applicable

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

France59 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oswestry Disability Index

Timeframe: Baseline

Oswestry Disability Index

Timeframe: 3 Months

Trial details

NCT IDNCT05203666

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-01

View on ClinicalTrials.gov More Degenerative Lumbar Spinal Stenosis trials