Alex Ghanayem, MD, Maywood, IL, USA; Mike Larson, DVM, Logan, UT, USAIntroduction: Threaded interbody cages have come into widespread use. Fusion rates are high but not perfect. Problems noted on postoperative radiographs after cage insertion include radiolucency around the cage, indicating a fibrous tissue at the bone–cage interface. Other problems include normal-appearing postoperative radiographs but failure of bony consolidation. Intrinsic and extrinsic factors have been modified in search of increasing fusion rates in cage constructs, including the use of bone graft substitutes and implantable direct current stimulation in a sheep model. External pulsed electromagnetic fields (PEMF) is another way to provide electrical stimulation to improve the fusion/bone graft incorporation process and may enhance the cage fusion rate. This study examines the efficacy of using an externally applied PEMF in promoting bone growth through and around an anterior lumbar cage construct in the ovine model.Methods: Twelve sheep underwent an anterior cage fusion procedure at the L4–5 level using a left retroperitoneal surgical approach. The interspace was distracted and a single working tube placed on the left lateral surface of the disc space. The interspace was then reamed and tapped. A threaded titanium fusion cage (Interfix; Medtronic-Sofamor Danek, Memphis, TN) was then placed transversely across the disc space. Cages were packed with morsilized autogenous ICBG. Six animals were randomly selected and fitted with a customized external PEMF device (Spinal Stim; Orthofix) that provided 4 hours of stimulation every 24-hour cycle. The other six animals did not receive stimulation and served as a control group. At 16 weeks after surgery, animals were euthanized. Specimens were removed en bloc from T12 to S1 and radiographed in the arteroposterior and lateral projections. Lateral flexion and extension radiographs were also obtained. The radiographs were blindly evaluated for the following characteristics: obvious lucency at the cage–vertebral end plate junctions, sclerosis or reactive bone at the cage–vertebral end plate junctions, no lucency or reactive bone at the cage–vertebral end plate junctions, definite bridging bone across the interspace and the absence or presence or motion, or the appearance of lucencies at the cage–vertebral end plate junctions on flexion-extension radiographs. Specimens were prepared for histologic evaluation and surface-stained with hemotoxylin and eoson. Histologic analysis was completed blindly using the following criteria: the presence or absence of a tight interface between the cage and the surrounding bone without fibrous tissue interposition, the presence or absence of bridging bone from one vertebral body, through the cage, to the other body and the presence or absence of bridging bone from one vertebral body, through the cage or around a portion of the cage, that extended to the other body. Criteria for a successful fusion included no lucency or motion on plain radiographs, the presence of tight cage–bone interfaces without fibrous tissue interposition and bridging bone through the cage on histologic evaluation. The lack of lucencies and motion on plain radiographs would not qualify as a successful fusion unless there were confirmation of fusion on the histologic analysis. Lucencies around the cages, motion on flexion-extension radiographs, fibrous tissue interposition at the cage–vertebral body interface and lack of bridging bone on histology would be classified as not fused.Results: All 12 sheep completed the protocol. One animal experienced transient weakness in the hind limb opposite to the side of cage insertion, which resolved spontaneously over the course of 3 days. Radiographs with lucencies always correlated with fibrous tissue at the cage–vertebral body interface on histologic evaluation. The absence of lucencies, however, did not always predict histologic fusion. Four of the six animals in the PEMF group were judged to have a successful fusion. In the control group, one animal was judged to be successfully fused and one was thought to have a partial fusion. If this control animal is considered a success, then the fusion rates was two of six in the control group.Discussion: Previous studies in sheep have shown recombinant human bone morphogenetic protein or internal direct current stimulation of an anterior cage construct can increase the fusion rate. It should be noted that radiographs without evidence of lucencies or motion did not always predict a successful fusion histologically, thus reaffirming a shortcoming of plain radiographs in assessing the success of a cage fusion. Radiographic bridging bone, however, was predictive of a successful fusion. This study has shown that the use of a nonimplantable PEMF device, with 4 hours of stimulation per day, also yields a significant increase in the fusion rate of an anterior cage–autogenous graft fusion construct.
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