Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Assiut University60 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Fusion

Interventions

Transforaminal Lumbar Interbody Fusion either open or minimally invasivePROCEDURE

Spinal fusion procedure through the intervertebral foramen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

• 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.

Time frame: 1 year

Data from ClinicalTrials.gov

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