A PROSPECTIVE RANDOMIZED STUDY COMPARING FIVE INSTRUMENTATION SYSTEMS FOR ONE AND TWO LEVEL LUMBAR ARTHRODESIS

Participants: G. Graziano, M. L. Greenfield, A. Clotfelter, J. Choe

Keywords: lumbar spinal fusion, spinal instrumentation,

Introduction

Low back pain is an important cause of disability and is frequently associated with disc disease, instability, spondylolisthesis, scoliosis and failed lumbar surgery. Lumbar arthrodesis is standard treatment for multi-level degenerative disc disease, multi-level laminectomy, failed lumbar surgery, lumbar instability, spondylolisthesis, and scoliosis. At the University of Michigan Hospital 150 to 200 fusion procedures are done yearly.

Fixation allows stabilization to the area of the arthrodesis, it can help reduce deformity, and it is able to be adapted to various spinal disorders. It has been demonstrated that the incidence of lumbar pseudoarthrosis has decreased with the use of spinal instrumentation allowing more rapid recovery and a return to a productive, non-painful lifestyle. The most common arthrodesis technique is a posterolateral transverse process fusion. Previous studies have documented that instrumentation lowers the incidence of pseudoarthrosis. The most common instrumentation systems are the Cotrel-Dubousset, the Texas Scottish Rite Hospital (TSRH), the Rogozinski Rod System, the Selby II Rod System, and the Isola System. These five systems vary in their adaptability, rigidity, ease of application, and bulk. The goal of this study is to distinguish differences between five spinal instrumentation systems used for one and two level lumbar spinal fusion: Cotrel-Dubousset, Texas Scottish Rite Hospital, Rogozinski Rod System, the Selby II Rod System, and the Isola System.

Materials and Methods

All patients scheduled having elective posterior lumbar arthrodesis were screened for this study. Patients considered for surgical intervention have failed conservative treatment consisting of physical therapy, back brace and non-steroidal anti-inflammatory medications. Those patients agreeing to participate were randomized to a treatment group.

Progress

100 patients have been enrolled into this study. All patients have completed a two-year follow up and data are currently being analyzed.