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 |
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.
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
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