Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis

August 31, 2017 updated by: Mahmoud Garamoun Abd El Zaher, Assiut University

Comparative Study Between Posterior Lumbar Interbody Fusion(PLF) and Intertransverse Process Fusion in Treatment of Spodylolithesis

The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach.

While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study we will try to identify the benefits and outcome of posterior lumbar interbody fusion and inter transverse process bone graft fusion.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lumbar spondylolisthesis

Exclusion Criteria:

  • infection of lumbar spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lumbar spondylolisthesis1
Procedure: Inter transverse bone grafting
Inter transverse process bone grafting by bone graft from illiac crest or other sites
ACTIVE_COMPARATOR: Lumbar spondylolisthesis 2
Procedure: Posterior lumbar interbody fusion
Lumbar fusion by screws and inter vertebral cage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back pain
Time Frame: 1year postoperative
Back pain severity grading mild, moderate, severe
1year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2017

Primary Completion (ANTICIPATED)

August 30, 2018

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (ACTUAL)

September 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lumbar spondylolisthesis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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