STUDY DESIGN: A prospective, nonblinded, multicenter study of outcomes in patients undergoing single-level anterior lumbar discectomy and interbody fusion with InFUSE Bone Graft. OBJECTIVE: To determine the safety and effectiveness of InFUSE Bone Graft applied to an absorbable collagen sponge in anterior lumbar interbody fusion with threaded cortical allografts. SUMMARY OF BACKGROUND DATA: In primates, InFUSE Bone Graft used with allograft dowels was shown to increase rates of interbody fusion by promoting osteoinduction and enhancing incorporation of the allograft. Recently, in a small series of human patients undergoing anterior lumbar interbody fusion with a tapered cylindrical metal fusion cage, InFUSE Bone Graft has been shown to promote osteoinduction and fusion. METHODS:Forty-six patients underwent a single-level anterior lumbar discectomy and interbody fusion at five investigational sites. They were randomly assigned to one of two groups, and the results in the investigational patients who received threaded cortical allograft dowels with InFUSE Bone Graft were compared with those in the control patients who received threaded allograft dowels with autogenous iliac crest bone graft. Patients' clinical outcomes were assessed using neurologic status, work status, and Oswestry Low Back Pain Disability, Short Form-36, and back and leg pain questionnaires. Anteroposterior, lateral, flexion-extension radiographs, and computed tomography scans were used to evaluate the progression of fusion at 6, 12, and 24 months after surgery. RESULTS: All patients who received InFUSE Bone Graft showed radiographic evidence of bony induction and early incorporation of the cortical allografts. All patients in this group had fusions at 12 months that remained fused at 24 months. At 12 and 24 months, the investigational group showed higher rates of fusion and improved neurologic status and back and leg pain when compared with the control group. There were no unanticipated adverse events related to the use of InFUSE Bone Graft. CONCLUSION: The use of InFUSE Bone Graft is a promising method of facilitating anterior intervertebral spinal fusion, decreasing pain, and improving clinical outcomes in patients who have undergone anterior lumbar fusion surgery with structural threaded cortical allograft bone dowels.
RCT Entities:
STUDY DESIGN: A prospective, nonblinded, multicenter study of outcomes in patients undergoing single-level anterior lumbar discectomy and interbody fusion with InFUSE Bone Graft. OBJECTIVE: To determine the safety and effectiveness of InFUSE Bone Graft applied to an absorbable collagen sponge in anterior lumbar interbody fusion with threaded cortical allografts. SUMMARY OF BACKGROUND DATA: In primates, InFUSE Bone Graft used with allograft dowels was shown to increase rates of interbody fusion by promoting osteoinduction and enhancing incorporation of the allograft. Recently, in a small series of humanpatients undergoing anterior lumbar interbody fusion with a tapered cylindrical metal fusion cage, InFUSE Bone Graft has been shown to promote osteoinduction and fusion. METHODS: Forty-six patients underwent a single-level anterior lumbar discectomy and interbody fusion at five investigational sites. They were randomly assigned to one of two groups, and the results in the investigational patients who received threaded cortical allograft dowels with InFUSE Bone Graft were compared with those in the control patients who received threaded allograft dowels with autogenous iliac crest bone graft. Patients' clinical outcomes were assessed using neurologic status, work status, and Oswestry Low Back Pain Disability, Short Form-36, and back and leg pain questionnaires. Anteroposterior, lateral, flexion-extension radiographs, and computed tomography scans were used to evaluate the progression of fusion at 6, 12, and 24 months after surgery. RESULTS: All patients who received InFUSE Bone Graft showed radiographic evidence of bony induction and early incorporation of the cortical allografts. All patients in this group had fusions at 12 months that remained fused at 24 months. At 12 and 24 months, the investigational group showed higher rates of fusion and improved neurologic status and back and leg pain when compared with the control group. There were no unanticipated adverse events related to the use of InFUSE Bone Graft. CONCLUSION: The use of InFUSE Bone Graft is a promising method of facilitating anterior intervertebral spinal fusion, decreasing pain, and improving clinical outcomes in patients who have undergone anterior lumbar fusion surgery with structural threaded cortical allograft bone dowels.
Authors: Michael Katsimihas; Christopher S Bailey; Khalil Issa; Jennifer Fleming; Patricia Rosas-Arellano; Stewart I Bailey; Kevin R Gurr Journal: Can J Surg Date: 2010-12 Impact factor: 2.089