Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.

Study Overview

• Status: Unknown
• Conditions: Spinal Fusion
• Intervention / Treatment: Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive

Detailed Description

The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults more than 18 years of age and less than 65 years of age..
• Degenerative or isthmic spondylolithesis Grade 1,2 and 3.
• Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural compression.
• Single level pathology involving L2-3, L3-4, L4-5 and or L5-S1.
• Symptoms not responding to conservative treatment for at least 3 months.

Exclusion Criteria:

• Previous spinal fusion or instrumentation.
• Spinal tumours, infection and fractures.
• Patients with severe osteoporosis
• BMI more than 35.
• Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome)
• Patients not willing to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: O-TLIF group; Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery.	Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive; Spinal fusion procedure through the intervertebral foramen
Other: MI-TLIF group; Spinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor.	Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive; Spinal fusion procedure through the intervertebral foramen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability index(Arabic version) 1 month	an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Fusion rate as assessed by Bridwell fusion score.	Grade I is defined as fusion with remodelling and trabeculae present; Grade II is an intact graft with incomplete remodelling and no lucency present; Grade III is an intact graft with potential lucency at the cranial or caudal end; Grade IV is absent fusion with collapse/resorption of the graft.	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: minimally invasive surgery; spine fusion
• Other Study ID Numbers: 6272829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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