Tadpole system as new lumbar spinal instrumentation

BACKGROUND There have been reports of serious complications associated with pedicle screw fixation, including nerve root injuries caused by accidental screw insertion. We have developed a new system of lumbar spinal instrumentation that we call Tadpole system. The purposes of this report were to show the results of a biomechanical study and the short-term outcome of a clinical study, as well as to determine the usefulness of this system. METHODS The Tadpole system lumbar spinal fusion is a hook-and-rod system according to which the spine is stabilized using 2 sets of 2 spinous processes each that are held in place by 4 hooks tandemly connected to a rod. The biomechanical study was done using 5 human lumbar cadaveric spines, and the range of motion (ROM) was examined in a non-treatment model, an injured model, a pedicle screw fixation model and a Tadpole system model. For the short-term clinical study the Tadpole system was used in 31 patients, and the factors analyzed were operation time, time required for spinal instrumentation, amount of intraoperative bleeding, postoperative improvement rate of the Japanese Orthopaedic Association (JOA) score for lumbar spinal disorders, instrumentation failure, spinous process fracture, spinal fluid leakage, nerve root injury, postoperative infection, and bone fusion 2 years after the operation. RESULTS The ROM in the Tadpole system model was slightly bigger than that in the pedicle screw fixation model, but smaller than that in the normal control model. These biomechanical data indicated that the Tadpole system provided fairly good stability. The mean operation time was 79 min, the mean time required for spinal instrumentation was 8 min, and the mean amount of intraoperative bleeding was 340 mL. The mean postoperative improvement rate of JOA score was 70.9 +/- 24.8%. Instrumentation failure (dislocation of a hook) occurred in one patient, and none of the patients developed spinous process fracture, spinal fluid leakage, nerve root injury, or postoperative infection. Two years after the operation, bone union was confirmed in 29 of the 31 patients (93.5%). CONCLUSION We conclude that this system is a useful, easy-to-use and safe spinal instrumentation technique for lumbar fusion surgery.