Lumbar interbody fusion using the Brantigan I/F Cage for posterior lumbar interbody fusion and the Variable Pedicle Screw Placement System: Two- year results from a Food and Drug Administration investigational device exemption clinical trial

Study Design. A carbon fiber-reinforced polymer cage implant filled with autologous bone was designed to separate the mechanical and biologic functions of posterior lumbar interbody fusion. Objectives. To test the safety and efficacy of the carbon cage with pedicle screw fixation in a 2- year prospective study performed at six centers under a protocol approved by the Food and Drug Administration, and to present the data supporting the Food and Drug Administration approved indications. Summary of Background Data. The success of posterior lumbar interbody fusion has been limited by mechanical and biologic deficiencies of the donor bone. Some failures of pedicle screw fixation may be attributable to the absence of adequate load sharing through the anterior column. Combining an interbody fusion device with pedicle screw fixation may address some limitations of posterior lumbar interbody fusion or pedicle screw fixation in cases that are more complex mechanically. Methods. This clinical study of posterior lumbar interbody fusion with pedicle screw fixation involved a prospective group of 221 patients. Results. Fusion success was achieved in 176 (98.9%) of 178 patients. In the management of degenerative disc disease in patients with prior failed discectomy surgery, clinical success was achieved in 79 (86%) of 92 patients, and radiographic bony arthrodesis in 91 (100%) of 91 patients. Disc space height, averaging 7.9 mm before surgery, was increased to 12.3 mm at surgery and maintained at 11.7 mm at 2 years. Fusion success was not diminished over multiple fusion levels. These results were significantly better than those reported in prior literature. Although significant surgical complications occurred, those attributable to the implant devices occurred less frequently and generally were minor. Conclusions. The Brantigan I/F Cage for posterior lumbar interbody fusion and the Variable Screw Placement System are safe and effective for the management of degenerative disc disease.