The Prone XLIF. A Pilot Study

Spinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03509389
• Other study ID #: TheProneXLIF v.1-11/1/18
• Status: Recruiting
• First received: April 14, 2018
• Last updated: April 25, 2018
• Start date: April 7, 2018
• Est. completion date: April 7, 2019

Study information

• Verified date: April 2018
• Source: Istituto Ortopedico Galeazzi
• Contact: Elena Cittera
• Phone: +390266214057
• Email: elena.cittera[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 7, 2019
• Est. primary completion date: April 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Diseases

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	Registration of intraoperative complications during surgery	intraoperative
Secondary	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
Secondary	Length of surgery	Evaluation of length of surgery	intraoperative
Secondary	Subsidence rate	Evaluation of subsidence rate at postoperative x-ray	in 5 days from surgery
Secondary	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