OBJECTIVE: This prospective, randomized study was performed to determine whether a new, in situ setting hydroxyapatite cement is as safe or effective as autologous cancellous bone graft for the treatment of metaphyseal bone voids secondary to trauma. This was a multicenter study including Level I trauma centers and university hospitals. Thirty-eight patients who sustained an acute closed or open type I fracture of the humerus, radius, ulna, femur, tibia, or calcaneus and had a traumatic bonevoid requiring grafting of the metaphyseal or cancellous bone area were enrolled. Open reduction and internal fixation of the fracture was performed with use of either autologous cancellous bone or BoneSource hydroxyapatite cement to fill traumatic metaphyseal voids. Main outcome measures included maintenance of reduction, fracture healing, pain at defect site, pain at donor site, and clinical function of the limb. RESULTS: Patients treated with BoneSource had an 83% success rate in maintaining reduction, whereas patients treated with autograft had a 67% success rate. A successful clinical outcome, as measured by a healed fracture with minimal to no pain, moderate to maximum function, and no or minor donor site complications, was seen in 69% of patients treated with BoneSource and 57% of patients treated with autograft. In patients with at least 1 year of follow-up, the overall success rate was 79% in the BoneSource group and 70% in the autograft group. CONCLUSION: BoneSource is safe and effective when used to fill traumatic metaphyseal bone voids. It is at least as good as autograft for treatment of these defects.
RCT Entities:
OBJECTIVE: This prospective, randomized study was performed to determine whether a new, in situ setting hydroxyapatite cement is as safe or effective as autologous cancellous bone graft for the treatment of metaphyseal bone voids secondary to trauma. This was a multicenter study including Level I trauma centers and university hospitals. Thirty-eight patients who sustained an acute closed or open type I fracture of the humerus, radius, ulna, femur, tibia, or calcaneus and had a traumatic bone void requiring grafting of the metaphyseal or cancellous bone area were enrolled. Open reduction and internal fixation of the fracture was performed with use of either autologous cancellous bone or BoneSource hydroxyapatite cement to fill traumatic metaphyseal voids. Main outcome measures included maintenance of reduction, fracture healing, pain at defect site, pain at donor site, and clinical function of the limb. RESULTS:Patients treated with BoneSource had an 83% success rate in maintaining reduction, whereas patients treated with autograft had a 67% success rate. A successful clinical outcome, as measured by a healed fracture with minimal to no pain, moderate to maximum function, and no or minor donor site complications, was seen in 69% of patients treated with BoneSource and 57% of patients treated with autograft. In patients with at least 1 year of follow-up, the overall success rate was 79% in the BoneSource group and 70% in the autograft group. CONCLUSION: BoneSource is safe and effective when used to fill traumatic metaphyseal bone voids. It is at least as good as autograft for treatment of these defects.
Authors: Esther M M Van Lieshout; Gerdine H Van Kralingen; Youssef El-Massoudi; Harrie Weinans; Peter Patka Journal: BMC Musculoskelet Disord Date: 2011-02-02 Impact factor: 2.362