Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

NCT ID: NCT03692845

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2021-10-31

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.

Conditions

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Spinal Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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O-TLIF group

Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery.

Group Type OTHER

Transforaminal Lumbar Interbody Fusion either open or minimally invasive

Intervention Type PROCEDURE

Spinal fusion procedure through the intervertebral foramen

MI-TLIF group

Spinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor.

Group Type OTHER

Transforaminal Lumbar Interbody Fusion either open or minimally invasive

Intervention Type PROCEDURE

Spinal fusion procedure through the intervertebral foramen

Interventions

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Transforaminal Lumbar Interbody Fusion either open or minimally invasive

Spinal fusion procedure through the intervertebral foramen

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amr Hatem Ahmed Mohammed

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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6272829

Identifier Type: -

Identifier Source: org_study_id

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