NCT02068768

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2016

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

February 19, 2014

Results QC Date

January 18, 2019

Last Update Submit

April 12, 2019

Conditions

Degenerative Disc Disease

Keywords

fusionlateral interbody fusion systemlumbar spinedegenerative disc disease

Outcome Measures

Primary Outcomes (1)

  • Fusion Rate

    Number of participants with fused disc space as measured radiographically

    12 months after device implantation

Secondary Outcomes (2)

  • Mean Oswestry Disability Index (ODI)

    preop, 3 mo, 6 mo, 12 mo post op

  • Visual Analog Scale (VAS) of Back Pain

    preop, 3 mo, 6 mo, 12 mo

Study Arms (1)

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)

Interventions

Avenue® L Interbody Fusion System (LDR Spine)DEVICE

PEEK, intervertebral cage for interbody fusion of the lumbar spine

Operated Subjects

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center for Spine and Orthopedics

Thornton, Colorado, United States

Location

Orthopedic Surgery

Atlanta, Georgia, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Location

Southern New York Neurosurgical Group

Johnson City, New York, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Limitations and Caveats

Poor enrollment led to early termination and low number of participants available for analysis

Results Point of Contact

Title
Clinical Affairs
Organization
Zimmer Biomet Spine
tammy.stinson2@zimmerbiomet.com
303-501-8571

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

July 15, 2013

Primary Completion

March 9, 2016

Study Completion

March 23, 2016

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)