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

LDR Medical

Status: Terminated

Conditions: Degenerative Disc Disease

Treatments: Device: Avenue® L Interbody Fusion System (LDR Spine)

Study type: Observational

Funder types: Industry

Identifiers

NCT02068768

AveL100

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 1 patient group

Operated Subjects

Description:

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

Treatment:

Device: Avenue® L Interbody Fusion System (LDR Spine)