The Prone XLIF. A Pilot Study

The Prone XLIF. An Observational Pilot Study Based on Prospective Study

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Diseases

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20161
    • Recruiting
    • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Registration of intraoperative complications during surgery	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	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.	in 5 days from surgery - 6 months follow-up
Length of surgery	Evaluation of length of surgery	intraoperative
Subsidence rate	Evaluation of subsidence rate at postoperative x-ray	in 5 days from surgery
Visual Analogic Score (VAS) leg and back	Evaluation of clinical outcomes using the VAS score, going from 0 to 10, where 0 means no pain and 10 the worst pain possible.	in 5 days from surgery - 6 months follow-up

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2018
• Primary Completion (Anticipated): April 7, 2019
• Study Completion (Anticipated): April 7, 2019

Study Registration Dates

• First Submitted: April 14, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: TheProneXLIF v.1-11/1/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No