Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - Any
Updated:4/2/2016
Start Date:August 2013
End Date:January 2016
Contact:Jane M Jacob, PhD
Email:Jane.Jacob@ldrspine.com
Phone:512-344-3371

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A Prospective, Multicenter, Open Label Clinical Study of the Safety andEfficacy of the Avenue L Interbody Spinal Fusion System Using the VerteBRIDGE Plating System and Supplemental Posterior Fixation

The purpose of this prospective clinical study is to examine the short-term safety and
efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat
one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.


Inclusion Criteria:

- Subjects must be candidates for on-label use of the Avenue L device (have
degenerative disc disease, use only at one or two contiguous levels, posterior
fixation must be used, autograft must be used in the interbody cage)

- Subject must be skeletally mature at the time of surgery, i.e. the subject must be at
least 21 years of age at the time of surgery

- Subject should have had a minimum of 6 months of non-operative treatment prior to
surgery

- The placement of the Avenue L device must be a primary surgery

- Subject must be willing to sign the consent form and be able to return for all follow
up visits.

Exclusion Criteria:

- Subject must not have had prior surgery at the operative level(s)

- Subject is known to have substance or alcohol addictions

- Subject has lateral curvature of the spine (scoliosis, all types)

- Subject is a prisoner

- Subject is pregnant

- Subject has an active infection or sepsis at the time of surgery

- Subject has any neuromuscular disorder that would preclude accurate neurologic
evaluations
We found this trial at
1
site
Johnson City, New York 13790
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from
Johnson City, NY
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