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.
METHODS
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.


OBJECTIVE
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.


BACKGROUND
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 notdiminished 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.
Brantigan
J W
JW
South Texas Orthopaedic and Spinal Surgery Associates, San Antonio, Texas 78240, USA.
Steffee
A D
AD
Lewis
M L
ML
Quinn
L M
LM
Persenaire
J M
JM
D000328:Adult; D000368:Aged; D001863:Bone Screws; D002244:Carbon; D005260:Female; D006801:Humans; D007403:Intervertebral Disc / Q000473:pathology / Q000601:surgery; D007405:Intervertebral Disc Displacement / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D013123:Spinal Fusion / Q000295:instrumentation* / Q000379:methods*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D002244:Carbon