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

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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: Avenue® L Interbody Fusion System (LDR Spine)

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Thornton, Colorado, United States
      • Center for Spine and Orthopedics
  • Georgia
    • Atlanta, Georgia, United States
      • Orthopedic Surgery
  • New Jersey
    • Neptune, New Jersey, United States
      • Jersey Shore University Medical Center
  • New York
    • Johnson City, New York, United States
      • Southern New York NeuroSurgical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be drawn from the patient populations of the physicians participating in the study. The principal investigators include community physicians in private practice as well as physicians affiliated with academic institutions.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Operated Subjects; 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); PEEK, intervertebral cage for interbody fusion of the lumbar spine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LDR Spine USA

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2013
• Primary Completion (Actual): March 9, 2016
• Study Completion (Actual): March 23, 2016

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: lumbar spine; fusion; degenerative disc disease; lateral interbody fusion system
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: AveL100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No