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

NCT05203666 | Completed

• 1 other identifier: 21Imagerie03
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Oswestry Disability Index

  Disability level evaluated with Oswestry Disability Index before intervention

  Baseline

• Oswestry Disability Index

  Disability level evaluated with Oswestry Disability Index after intervention

  3 Months

Secondary Outcomes (4)

• Visual Analog Scale for pain

  Baseline

• Visual Analog Scale for pain

  3 Months

• Variation of foraminal area

  Baseline

• Variation of foraminal area

  3 Months

Study Arms (1)

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.

Other: percutaneous removable interspinous process

Interventions

percutaneous removable interspinous process OTHER

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

degenerative lumbar spinal stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• removable percutaneous IPS treatment
• attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

Related Publications (1)

• 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.

  PMID: 35641830 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 24, 2022
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: October 21, 2021
• Last Updated: January 24, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)