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KMID : 1150320230190020062
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Journal of Korean Society of Geriatric Neurosurgery
2023 Volume.19 No. 2 p.62 ~ p.67
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Exploratory clinical trial results of a prospective comparative study between activin A/BMP-2 chimera (AB204) and autograft in one-level transforaminal lumbar interbody fusion
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Cheon Tae-Min
Ryu Dal-Sung
Yoon Seung-Hwan
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Abstract
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Objective : Bone morphogenetic protein 2 (BMP-2) shows promise in clinical applications for promoting bone fusion. However, high doses of BMP2 can lead to adverse effects. As an alternative, the activin A/BMP-2 chimera (AB204) has been studied for its potential to overcome the limitations of BMP2 and enhance bone formation. In this clinical trial, we intended to evaluate the efficacy of AB204 for bone fusion efficacy and stability in patients requiring one-level spinal fusion.
Methods : We conducted a single-blind, randomized, active-controlled clinical trial to evaluate the efficacy and stability of AB204 for bone fusion. Interbody fusion was performed by inserting AB204 or a bone autograft into the cage of patients requiring one-level transforaminal lumbar interbody fusion operation. Patients in the AB204 group received calcium phosphate with AB204 (2 mg), whereas those in the control group received only local bone transplants. At 24 weeks after surgery, computed tomography and radiography were performed to assess the degree of interbody fusion. The visual analog scale, Oswestry disability index, and perioperative data were also analyzed.
Results : Through the direct administration of AB204, successful bone fusion was achieved in all patients in the AB204 group, with no side effects such as ectopic bone formation, vertebral osteolysis, cancer, or inflammation. In the control group, one patient exhibited Bridwell grade II fusion along with screw loosening, whereas the remaining patients experienced no complications.
Conclusion : This study demonstrated the potential of AB204 as a bone substitute to achieve successful bone fusion in patients undergoing one-level spinal fusion.
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KEYWORD
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Bone morphogenetic proteins, Bone substitutes, Spinal fusion
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