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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: Avenue® L Interbody Fusion System (LDR Spine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Operated Subjects<br>Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 | Device: Avenue® L Interbody Fusion System (LDR Spine)<br>* PEEK, intervertebral cage for interbody fusion of the lumbar spine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Rate | Number of participants with fused disc space as measured radiographically | 12 months after device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Oswestry Disability Index (ODI) | 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. | preop, 3 mo, 6 mo, 12 mo post op | 
| Visual Analog Scale (VAS) of Back Pain | 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. | preop, 3 mo, 6 mo, 12 mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fusion, lateral interbody fusion system, lumbar spine, degenerative disc disease