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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02068768
• Other study ID #: AveL100
• Status: Terminated
• Start date: July 15, 2013
• Est. completion date: March 23, 2016

Study information

• Verified date: April 2019
• Source: LDR Spine USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 23, 2016
• Est. primary completion date: March 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• Avenue® L Interbody Fusion System (LDR Spine)
PEEK, intervertebral cage for interbody fusion of the lumbar spine

Locations

Country	Name	City	State
United States	Orthopedic Surgery	Atlanta	Georgia
United States	Southern New York Neurosurgical Group	Johnson City	New York
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Center for Spine and Orthopedics	Thornton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
LDR Spine USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion Rate	Number of participants with fused disc space as measured radiographically	12 months after device implantation
Secondary	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
Secondary	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