Outcomes of Degenerative Disc Disease Patients Treated With an Anterior-Only Fusion Using InQu Bone Graft

Summary

The purpose of this study is to report the radiographic, clinical, and functional outcomes of a consecutive series of patients diagnosed with single or bilateral degenerative disc disease between L4 and S1, that have been treated with an anterior lumbar interbody fusion (ALIF), anterior only surgical approach, and InQu Bone Graft Extender and Substitute for bony fusion and instrumentation.

Patients that decide to undergo an Anterior Lumbar Interbody Fusion (ALIF) surgery \[a surgical procedure that joins two or more lumbar vertebrae (small bones of the spine) together into one solid bony structure by approaching the spine through the abdomen (front of the body) and placing a bone graft in between the vertebral bodies where the disc usually lies\], are invited to participate in an orthopaedic research study.

This study will compare patients that have been treated with an anterior lumbar interbody fusion using InQu Bone Graft Extender \& Substitute to published data for a stand alone spinal fusion surgery, where InFuse bone graft is placed between the transverse processes \[small bony projections off the right and left side of each bone in your spine\] of the affected vertebrae.

X-rays, daily activities, and how patients are doing will be evaluated at specific time points during this study.

The hypothesis of this study is that patients diagnosed with degenerative disc disease treated with an anterior lumbar interbody fusion, anterior only surgical approach (incision through the abdomen), using InQu Bone Graft Extender and Substitute and instrumented fixation have comparable radiographic (x-rays), functional (daily activities), and clinical (how the patient is doing) outcomes when compared to published data for use of InFuse in stand-alone fusion.

Conditions

• Degenerative Disc Disease

Interventions

PROCEDURE

One-level or two-level anterior lumbar interbody fusion

Patients electing to receive a one-level or two-level, anterior approach only (incision through the front), lumbar interbody fusion in order to treat degenerative disc disease (at one or two levels in the spine), and meeting all other inclusion criteria, are eligible for enrollment into the study.

BIOLOGICAL

InQu Bone Graft Extender and Substitute mixed with BMAC

Surgeries utilizing InQu Bone Graft Extender and Substitute during the anterior lumbar interbody fusion surgical procedure will be elected for inclusion. InQu will be mixed with BMAC (bone marrow aspirate concentrate), which will be prepared using the SmartPRep2 centrifuge. Patients opting to use a grafting alternative will not meet inclusion criteria, and will not be eligible to enroll in this study.

DEVICE

Synthes Spinal Instrumentation

Synthes Spinal Instrumentation will be used during surgery as spinal stabilization.

Sponsors & Collaborators

• National Center of Innovation for Biomaterials in Orthopaedic Research

  collaborator UNKNOWN

• ISTO Technologies, Inc.

  collaborator INDUSTRY

• Kansas Joint and Spine Institute

  lead NETWORK

Principal Investigators

• Mark C Whitaker, MD · Kansas Joint and Spine Institute

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2015-03-31

Completion

2015-05-31

Countries

• United States

Study Locations