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The Prone XLIF. A Pilot Study

Sponsor
Istituto Ortopedico Galeazzi (Other)
Overall Status
Unknown status
CT.gov ID
NCT03509389
Collaborator
(none)
25
Enrollment
1
Location
12
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational prospective study to evaluate the feasibility, effectiveness and the rate of complications of the XLIF (Extreme Lateral Interbody Fusion) performed in prone position to treat spinal diseases of the lumbar region.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Prone XLIF. An Observational Pilot Study Based on Prospective Study
    Actual Study Start Date :
    Apr 7, 2018
    Anticipated Primary Completion Date :
    Apr 7, 2019
    Anticipated Study Completion Date :
    Apr 7, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Complication rate [intraoperative]

      Registration of intraoperative complications during surgery

    Secondary Outcome Measures

    1. Oswestry Disability Index [in 5 days from surgery - 6 months follow-up]

      Evaluation of clinical outcomes using Oswestry Disability Index (ODI) questionnaire. It is a scaled questionnaire from 0 to 100 in which the higher the value, the worst the outcome.

    2. Length of surgery [intraoperative]

      Evaluation of length of surgery

    3. Subsidence rate [in 5 days from surgery]

      Evaluation of subsidence rate at postoperative x-ray

    4. Visual Analogic Score (VAS) leg and back [in 5 days from surgery - 6 months follow-up]

      Evaluation of clinical outcomes using the VAS score, going from 0 to 10, where 0 means no pain and 10 the worst pain possible.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥ 18

    • Patients suffering from lumbar spinal disease that requires a circumferential fusion

    • Patients suitable to undergo spinal fusion with an XLIF technique (according to the label indication/contraindications)

    • Patients who are willing and able to provide written informed consent to surgery and study

    Exclusion Criteria:

    • a congenital or post-traumatic vertebral abnormality at the target level

    • patients with a previous abdominal retroperitoneal surgery

    • patients that refuses/not suitable to undergo a XLIF surgery in prone position

    • subjects that are unable to provide a written informed consent to surgery and study

    • subjects that are unable to will or intend

    • pregnant women (declared before surgery)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Istituto Ortopedico Galeazzi Milano Italy 20161

    Sponsors and Collaborators

    • Istituto Ortopedico Galeazzi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Ortopedico Galeazzi
    ClinicalTrials.gov Identifier:
    NCT03509389
    Other Study ID Numbers:
    • TheProneXLIF v.1-11/1/18
    First Posted:
    Apr 26, 2018
    Last Update Posted:
    Apr 26, 2018
    Last Verified:
    Apr 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Spinal Diseases

    Study Results

    No Results Posted as of Apr 26, 2018