Therapeutic exploratory study of KCB-1B for patients with tibial shaft fracture

INTERVENTION: Arm P:A biodegradable gelatin hydrogel carrier Arm L:A total dosage of 800 microgram of KCB‐1 in a biodegradable gelatin hydrogel carrier Arm H:A total dosage of 2400 microgram of KCB‐1 in a biodegradable gelatin hydrogel carrier CONDITION: Tibial shaft fracture PRIMARY OUTCOME: 1)Bone union at 24 weeks after administration; 2)Date of a bone union; 3)Number and degree of adverse effects SECONDARY OUTCOME: 1)Secondary intervention; 2)Date of start full‐weight bearing; 3)Tenderness or pain and period to disappearance of those; 4)Aftereffect; 5)Serum KCB‐1 level ; 6)Serum anti‐KCB‐1B antibody INCLUSION CRITERIA: 1)Transverse or oblique tibial shaft fracture 2)Closed fracture or open fracture classified as Gustilo type1 treated with intramedullary nailing