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

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Operated Subjects	Avenue® L Interbody Fusion System (LDR Spine)	Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1

Primary Outcome Measures

Name	Time	Method
Fusion Rate	12 months after device implantation	Number of participants with fused disc space as measured radiographically

Secondary Outcome Measures

Name	Time	Method
Mean Oswestry Disability Index (ODI)	preop, 3 mo, 6 mo, 12 mo post op	The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Visual Analog Scale (VAS) of Back Pain	preop, 3 mo, 6 mo, 12 mo	The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either "no pain" or "worst imaginable pain". The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.

Locations (4): Southern New York Neurosurgical Group
🇺🇸
Johnson City, New York, United States
Orthopedic Surgery
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Atlanta, Georgia, United States
Jersey Shore University Medical Center
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Neptune, New Jersey, United States
Center for Spine and Orthopedics
🇺🇸
Thornton, Colorado, United States