We evaluated the efficacy of Escherichia coli-derived recombinant human bone morphogenetic protein-2 (E-BMP-2) in a mini-pig model of spinal anterior interbody fusion. A total of 14 male mini-pigs underwent three-level anterior lumbar interbody fusion using polyether etherketone (PEEK) cages containing porous hydroxyapatite (HA). Four groups of cages were prepared: 1) control (n = 10 segments); 2) 50 μg E-BMP-2 (n = 9); 3) 200 μg E-BMP-2 (n = 10); and 4) 800 μg E-BMP-2 (n = 9). At eight weeks after surgery the mini-pigs were killed and the specimens were evaluated by gross inspection and manual palpation, radiological evaluation including plain radiographs and micro-CT scans, and histological analysis. Rates of fusion within PEEK cages and overall union rates were calculated, and bone formation outside vertebrae was evaluated. One animal died post-operatively and was excluded, and one section was lost and also excluded, leaving 38 sites for assessment. This rate of fusion within cages was 30.0% (three of ten) in the control group, 44.4% (four of nine) in the 50 μg E-BMP-2 group, 60.0% (six of ten) in the 200 μg E-BMP-2 group, and 77.8% (seven of nine) in the 800 μg E-BMP-2 group. Fusion rate was significantly increased by the addition of E-BMP-2 and with increasing E-BMP-2 dose (p = 0.046). In a mini-pig spinal anterior interbody fusion model using porous HA as a carrier, the implantation of E-BMP-2-loaded PEEK cages improved the fusion rate compared with PEEK cages alone, an effect that was significantly increased with increasing E-BMP-2 dosage.

Cite this article: Bone Joint J 2013;95-B:217–23.

In patients with osteoporosis there is always a strong possibility that pedicle screws will loosen. This makes it difficult to select the appropriate osteoporotic patient for a spinal fusion. The purpose of this study was to determine the correlation between bone mineral density (BMD) and the magnitude of torque required to insert a pedicle screw. To accomplish this, 181 patients with degenerative disease of the lumbar spine were studied prospectively. Each underwent dual-energy x-ray absorptiometry (DEXA) and intra-operative measurement of the torque required to insert each pedicle screw. The levels of torque generated in patients with osteoporosis and osteopenia were significantly lower than those achieved in normal patients. Positive correlations were observed between BMD and T-value at the instrumented lumbar vertebrae, mean BMD and mean T-value of the lumbar vertebrae, and mean BMD and mean T-value of the proximal femur. The predictive torque (Nm) generated during pedicle screw insertion was [-0.127 + 1.62 × (BMD at the corresponding lumbar vertebrae)], as measured by linear regression analysis. The positive correlation between BMD and the maximum torque required to insert a pedicle screw suggests that pre-operative assessment of BMD may be useful in determining the ultimate strength of fixation of a device, as well as the number of levels that need to be fixed with pedicle screws in patients who are suspected of having osteoporosis.