Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Study Overview
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Brief Summary
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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
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The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.

Official Title
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Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Conditions
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Spinal Fusion

Intervention / Treatment
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* Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: O-TLIF group<br>Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery. | Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive<br>* Spinal fusion procedure through the intervertebral foramen<br>|
| Other: MI-TLIF group<br>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<br>* Spinal fusion procedure through the intervertebral foramen<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spine fusion, minimally invasive surgery