Comparative Study Between Posterior Lumbar Interbody Fusi... | NCT03271060

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Estimated

Primary Completion Date

Aug 30, 2018Estimated

Completion Date

Sep 1, 2019Estimated

First Submitted Date

Aug 31, 2017

First Submission Date that Met QC Criteria

Aug 31, 2017

First Posted Date

Sep 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2017

Last Update Posted Date

Sep 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lumbar spondylolisthesis1	Active Comparator		Procedure: Inter transverse bone grafting
Lumbar spondylolisthesis 2	Active Comparator		Procedure: Posterior lumbar interbody fusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Posterior lumbar interbody fusion	Procedure	Lumbar fusion by screws and inter vertebral cage	Lumbar spondylolisthesis 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

lumbar spondylolisthesis

Exclusion Criteria:

infection of lumbar spine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Garamoun, Resident	Contact	201091123869		Garamoun.mahmoud@yahoo.com

Overall Officials

Not provided

Locations

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D013169	Spondylolysis
D055009	Spondylosis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases