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The Prone XLIF. A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03509389
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

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
Spinal Diseases

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Study Type : Observational
Estimated 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 : April 7, 2018
Estimated Primary Completion Date : April 7, 2019
Estimated Study Completion Date : April 7, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Complication rate [ Time Frame: intraoperative ]
    Registration of intraoperative complications during surgery


Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 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 [ Time Frame: intraoperative ]
    Evaluation of length of surgery

  3. Subsidence rate [ Time Frame: in 5 days from surgery ]
    Evaluation of subsidence rate at postoperative x-ray

  4. Visual Analogic Score (VAS) leg and back [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by a lumbar spinal disease, indicated for surgery requiring a lateral XLIF approach to the lumbar spine, eligible to perform the approach in a prone position.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509389


Contacts
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Contact: Elena Cittera +390266214057 elena.cittera@grupposandonato.it

Locations
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Italy
IRCCS Istituto Ortopedico Galeazzi Recruiting
Milano, Italy, 20161
Contact: Elena Cittera    +390266214057    elena.cittera@grupposandonato.it   
Sponsors and Collaborators
Istituto Ortopedico Galeazzi

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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03509389     History of Changes
Other Study ID Numbers: TheProneXLIF v.1-11/1/18
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases