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

N/ATerminatedNCT02068768

LDR Spine USA13 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Disc Disease

Interventions

Avenue® L Interbody Fusion System (LDR Spine)DEVICE

PEEK, intervertebral cage for interbody fusion of the lumbar spine

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

Fusion Rate

Number of participants with fused disc space as measured radiographically

Time frame: 12 months after device implantation

Secondary Outcomes

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.

Time frame: 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.

Time frame: preop, 3 mo, 6 mo, 12 mo

Data from ClinicalTrials.gov

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