Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Not Applicable

• Conditions: Spinal Fusion
• Interventions: Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive

• Registration Number: NCT03692845
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-01
• Last Update Submitted: 2018-10-01
• Study First Posted: 2018-10-02
• Last Update Posted: 2018-10-02
• Study Start: 2018-11
• Primary Completion: 2020-11
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
O-TLIF group	Transforaminal Lumbar Interbody Fusion either open or minimally invasive	Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery.
MI-TLIF group	Transforaminal Lumbar Interbody Fusion either open or minimally invasive	Spinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
• Fusion rate as assessed by Bridwell fusion score.	1 year	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.