Objective: To investigate the clinical application of self-setting CPC loading rhBMP-2 for repair of bone defects and to evaluate the clinical effect and safety.
Methods: From June 2006 to September 2007, 112 bone defects patients were treated by CPC loading rhBMP-2 (rhBMP-2/CPC group) or CPC (control group). The range of bone defect was from 1 cm x 1 cm x 1 cm to 4 cm x 3 cm x 3 cm. In the control group, 63 patients included 31 males and 32 females, aging from 17 to 70 years with an average of 47.4 years. The bone defects were located as follows: calcaneus in 19 patients, tibial plateau in 20 patients, proximal humerus in 8 patients, distal radius in 9 patients and thoracolumbar vertebrae in 7 patients. In the rhBMP-2/CPC group, 49 patients included 31 males and 18 females, aging from 16 to 68 years with an average of 45.6 years. The bone defects were located as follows: calcaneus in 11 patients, tibial plateau in 16 patients, proximal humerus in 7 patients, distal radius in 2 patients, distal tibia in 2 patients and thoracolumbar vertebrae in 11 patients. All defects were repaired with rhBMP-2/CPC (2-5 g) and CPC (2-50 g) in the rhBMP-2/CPC group and the control group, respectively.
Results: A total of 108 patients got primary healing after operation. Incisions oozing light yellow fluids were found in 4 patients (control group in 1, rhBMP-2/CPC group in 3), and then healed through dressing changes and taking glucocorticoid. There were no allergic or toxic reaction, no rush or high fever, no fluctuation of hepatic and renal function, blood routine, CRP and urine routine. All patients were followed up for 12 to 24 months (mean 13.2 months). The X-ray examination showed that the implanted material was firmly bonded to the bone at the interface and the anatomic contour of the bone at the sites of defects was successfully restored, and no ablation occurred. All patients got bone union after 3 months of operation. The movement and function of flexion and extension of affected limbs recovered to the normal level.
Conclusion: Repairing bone defects with rhBMP-2/CPC is safe and effective. Using rhBMP-2/CPC is a promising therapy to deal with bone defects.