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OpenTrials
Completed

NCT Number: NCT05203666

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

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.

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Key information

Conditions

Degenerative Lumbar Spinal Stenosis Neurologic Intermittent Claudication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

percutaneous removable interspinous process

Other

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

Primary outcomes

  1. Oswestry Disability Index

    Time frame: Baseline

    Disability level evaluated with Oswestry Disability Index before intervention

  2. Oswestry Disability Index

    Time frame: 3 Months

    Disability level evaluated with Oswestry Disability Index after intervention

Secondary outcomes

  1. Visual Analog Scale for pain

    Time frame: Baseline

    Pain level from 0 (no pain) to 100 (unbearable pain) before intervention

  2. Visual Analog Scale for pain

    Time frame: 3 Months

    Pain level from 0 (no pain) to 100 (unbearable pain) after intervention

  3. Variation of foraminal area

    Time frame: Baseline

    Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan

  4. Variation of foraminal area

    Time frame: 3 Months

    Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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.

Acronym: LOBSTER

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2022
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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