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

NCT ID: NCT02068768

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-15
• Study Completion Date: 2016-03-23

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.

Conditions

Degenerative Disc Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Operated Subjects

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

Avenue® L Interbody Fusion System (LDR Spine)

Intervention Type: DEVICE

PEEK, intervertebral cage for interbody fusion of the lumbar spine

Interventions

Avenue® L Interbody Fusion System (LDR Spine)

PEEK, intervertebral cage for interbody fusion of the lumbar spine

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LDR Spine USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

AveL100

Identifier Type: -

Identifier Source: org_study_id