Infuse Bone Graft

Summary

This study focuses on individuals who have been diagnosed with degenerative disc disease at one or more levels of their spine and who have not responded to non-surgical treatments. The purpose of the study is to evaluate the investigational use of the Infuse Bone Graft in combination with the Capstone Spinal System (a spinal spacer device) and an implantable, metal rod and screw system plus autograft bone (the patient's own bone) to determine whether it is safe and effective when used in a transforaminal lumbar interbody fusion (TLIF) surgery. TLIF is a surgical procedure to make two or three vertebrae grow together (fuse). The Infuse Bone Graft consists of a man-made version of the BMP-2 protein, which is a protein that occurs naturally in humans and has been shown to help with forming bone.


Inclusion Criteria

  • I.1. Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression, manifested by:
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion At One Or Two Levels Using Infuse Bone Graft and The Capstone Spinal System with Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine

Details
Disease Type/Condition

Orthopaedics

Principal Investigator

Bae, Hyun

Age Group

Adult

Phase

N/A

IRB Number

STUDY00000290

ClinicalTrials.gov ID

NCT04073563

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Orthopaedics

Principal Investigator

Bae, Hyun

Age Group

Adult

Phase

N/A

IRB Number

MDT17074SD1706

ClinicalTrials.gov ID

NCT04073563

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?