NCT03271060

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

August 31, 2017

Last Update Submit

August 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Back pain

    Back pain severity grading mild, moderate, severe

    1year postoperative

Study Arms (2)

Lumbar spondylolisthesis1

ACTIVE COMPARATOR
Procedure: Inter transverse bone grafting

Lumbar spondylolisthesis 2

ACTIVE COMPARATOR
Procedure: Posterior lumbar interbody fusion

Interventions

Lumbar fusion by screws and inter vertebral cage

Lumbar spondylolisthesis 2

Inter transverse process bone grafting by bone graft from illiac crest or other sites

Lumbar spondylolisthesis1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lumbar spondylolisthesis

You may not qualify if:

  • infection of lumbar spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Mahmoud Garamoun, Resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Posterior inter body fusion and inter transverse process bone graft
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

September 1, 2017

Primary Completion

August 30, 2018

Study Completion

September 1, 2019

Last Updated

September 1, 2017

Record last verified: 2017-08