Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
Stopped early
Conditions studied: Degenerative Disc Disease
In brief
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.
Key facts
- Study ID
- NCT02068768
- Run by
- LDR Spine USA
- People needed
- 13
- Starts
- 2013-07-15
- Expected to finish
- 2016-03-23
- Last updated by the study team
- 2019-07-05
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Center for Spine and Orthopedics — Thornton, Colorado, United States
- Orthopedic Surgery — Atlanta, Georgia, United States
- Jersey Shore University Medical Center — Neptune City, New Jersey, United States
- Southern New York Neurosurgical Group — Johnson City, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.