Status:

UNKNOWN

Autologous Bone Marrow Concentrate in Elective Tranforaminal Lumbar Interbody Fusion Surgery

Lead Sponsor:

Pei-Yuan Lee, MD

Collaborating Sponsors:

Aeon Biotechnology Corporation

Conditions:

Bone Marrow

Spinal Fusion

Eligibility:

All Genders

20-70 years

Phase:

NA

Brief Summary

This study aims to evaluate the effect of bone marrow concentration on bone healing and spinal fusion by comparing clinical and imaging outcomes between patients receiving transforaminal lumbar intebo...

Detailed Description

Spinal arthrodesis has become the mainstay of treatment for severe spinal deformity, spinal instability, spondylolisthesis, and symptomatic degenerative disease. Its primary goal is to develop an osse...

Eligibility Criteria

Inclusion

  • With indication of transforaminal lumbar decomprassion and interbody fusion, ex. spondylolisthesis, symptomatic degenerative disease, spinal instability.
  • Involved levels between T12 and S1
  • Involved levels less than three levels
  • Age between 20 and 70 years

Exclusion

  • With prior history of spinal surgery
  • With current or prior history of tumor, trauma or infection at spine
  • With current diagnosis of coagulopathy
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup

Key Trial Info

Start Date :

August 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2020

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03793530

Start Date

August 1 2017

End Date

December 1 2020

Last Update

April 14 2020

Active Locations (1)

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Show Chwan Memorial Hospital

Changhua, Changhua, Taiwan, 500