Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
156
Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.
Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.
Chinese PLA General Hosptial
Beijing, China
Bone graft fusion rate
Time frame: 24weeks after surgery
Bone defect healing rate
Time frame: 4 and 12 weeks after surgery
New bone formation rate
Time frame: 4, 12 and 24 weeks after surgery
SF-36 scale
Time frame: 24 weeks after surgery
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