Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Amr Hatem Ahmed Mohammed，Assiut University

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

November 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Oswestry Disability index(Arabic version) 1 month[ Time Frame: 1 month ]

an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

• Fusion rate as assessed by Bridwell fusion score.[ Time Frame: 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.

Descriptive Information

Brief Title ^ICMJE

Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Official Title ^ICMJE

Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive
Spinal fusion procedure through the intervertebral foramen

Study Arms

Other: O-TLIF group
Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery.
Other: MI-TLIF group
Spinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2021

Estimated Primary Completion Date

November 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Amr Hatem Ahmed Mohammed，Assiut University

Study Sponsor ^ICMJE

Assiut University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Assiut University

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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