A CLINICAL INVESTIGATION OF A FUSION DEVICE FOR ANTERIOR LUMBAR FUSION IN PATIENTS WITH SYMPTOMATIC DEGENERATIVE DISC DISEASE

Participants: G. Graziano, P. Taheri, J. Sweeney, M.L. Greenfield, A. Clotfelter

Keywords: anterior spinal fusion, laparoscopic approach, degenerative disc disease

Introduction

This is an FDA study of a fusion device, designed to be resistant to bending or breakage and to resist migration. A successful fusion with this device should lead to less pain for the patient and increased functional capacity. The surgical procedure is also expected to maintain disc height. Because the surgery is accomplished laparoscopically, patients may recover faster with less blood loss, shorter hospital stay, minimal scarring, minimal tissue dissection and resection, and enhanced vision for the operating surgeon.

The goals of this IDE study are to assess the safety and effectiveness of the anterior spinal fusion performed laparoscopically. The effects of interest are radiographically demonstrated fusion, maintenance of disc height, and improvement in pain, functional status, neurological status, and general health status.

Materials and Methods

Study patients received an anterior spinal fusion surgical procedure utilizing the study device. Post-operative follow-up data were obtained at 3 months, 6 months, 12 months and 24 months.

Progress

Three hundred subjects were enrolled at seventeen sites across the United States. Seven University of Michigan patients were enrolled, all of whom have completed 24 month follow-up. The last patients enrolled in the study at other sites will complete 24 month follow-up in 2001. Clinical and radiographic data are being compiled and will be analyzed by the study sponsor.