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

NCT05203666 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2022-01-24

No results posted yet for this study

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.

Conditions

  • Degenerative Lumbar Spinal Stenosis
  • Neurologic Intermittent Claudication

Interventions

OTHER

percutaneous removable interspinous process

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-06-01
Completion
2021-10-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203666 on ClinicalTrials.gov