J Kenneth Burkus1. 1. Spine Service, The Hughston Clinic, Columbus, Georgia 31908-9517, USA. jkb66@knology.net
Abstract
OBJECT: The author reports the clinical and radiographic outcomes obtained in three prospective multicenter clinical trials in which recombinant human bone morphogenetic protein-2 (rhBMP-2) was used in anterior lumbar interbody fusion (ALIF). METHODS:Stand-alone interbody fusion cages were used, and supplemental fixation was not performed as part of the study protocol. Patients were randomly assigned to one of two ALIF groups: one in which autologous iliac crest bone graft was used (control) and one in which an rhBMP-2-coated absorbable collagen sponge was placed (investigational group). In all patients who underwent rhBMP-2-augmented fusion, imaging demonstrated evidence of bone induction and early incorporation of the cortical allografts. Overall, more expedient clinical improvements and higher success rates were observed in the rhBMP-2 group. CONCLUSIONS: In these studies it was shown that rhBMP-2 is a safe and effective material for facilitating ALIF and for decreasing pain and improving clinical outcomes.
RCT Entities:
OBJECT: The author reports the clinical and radiographic outcomes obtained in three prospective multicenter clinical trials in which recombinant humanbone morphogenetic protein-2 (rhBMP-2) was used in anterior lumbar interbody fusion (ALIF). METHODS: Stand-alone interbody fusion cages were used, and supplemental fixation was not performed as part of the study protocol. Patients were randomly assigned to one of two ALIF groups: one in which autologous iliac crest bone graft was used (control) and one in which an rhBMP-2-coated absorbable collagen sponge was placed (investigational group). In all patients who underwent rhBMP-2-augmented fusion, imaging demonstrated evidence of bone induction and early incorporation of the cortical allografts. Overall, more expedient clinical improvements and higher success rates were observed in the rhBMP-2 group. CONCLUSIONS: In these studies it was shown that rhBMP-2 is a safe and effective material for facilitating ALIF and for decreasing pain and improving clinical outcomes.
Authors: Mostyn R N O Yong; Siamak Saifzadeh; Mia Woodruff; Geoffrey N Askin; Robert D Labrom; Dietmar W Hutmacher; Clayton J Adam Journal: Eur Spine J Date: 2013-11-20 Impact factor: 3.134
Authors: Hsin Chuan Pan; Soonchul Lee; Kang Ting; Jia Shen; Chenchao Wang; Alan Nguyen; Emily A Berthiaume; Janette N Zara; A Simon Turner; Howard B Seim; Jin Hee Kwak; Xinli Zhang; Chia Soo Journal: Am J Pathol Date: 2017-05-11 Impact factor: 4.307