A Randomized Controlled Trial of Lumbar Posterolateral Fusion in Combination with Platelet-Rich Plasma

Abstract

Introduction Platelet-rich plasma (PRP) has been reported to be a source of autologous growth factors (PDGF and TGF-β) that enhance bone formation. However, PRP has failed to improve fusion rates, perhaps due to suboptimal levels of growth factors. We began a Phase 1 study in July 2009, the purposes of which were to produce highly concentrated PRP enriched in growth factors, to monitor side effects, and to determine subsequent fusion rates. This is the first randomized controlled trial to investigate the potential advantages of using PRP in posterolateral fusion. Platelet-rich plasma (PRP) has been reported to be a source of autologous growth factors (PDGF and TGF-β) that enhance bone formation. However, PRP has failed to improve fusion rates, perhaps due to suboptimal levels of growth factors. We began a Phase 1 study in July 2009, the purposes of which were to produce highly concentrated PRP enriched in growth factors, to monitor side effects, and to determine subsequent fusion rates. This is the first randomized controlled trial to investigate the potential advantages of using PRP in posterolateral fusion. Materials and Methods Thirty-nine patients diagnosed with spinal canal stenosis were divided equally into “PRP” and “control” groups. The PRP patients underwent posterolateral fusion with instrumentation using autograft bone plus PRP, while control patients underwent the same procedure minus PRP. In the PRP group, one unit of whole blood (400 mL) was drawn from each patient at the beginning of surgery and centrifuged to extract platelets. Twenty mL of PRP was obtained, to which thrombin and CaCl2 were added to form a platelet gel for application to the surgical field. Bone fusion was periodically assessed using X-ray and CT. Results The average platelet concentration was 7.7-fold higher in the PRP than plasma. Growth factors released from the platelet gel were more than 50-fold concentrated compared with blood levels. No significant adverse events were observed. Bone union was observed in all patients. The average period was 7.8 months in the PRP group, and 9.8 months in the control group. The average platelet concentration was 7.7-fold higher in the PRP than plasma. Growth factors released from the platelet gel were more than 50-fold concentrated compared with blood levels. No significant adverse events were observed. Bone union was observed in all patients. The average period was 7.8 months in the PRP group, and 9.8 months in the control group. Conclusion In the present study, bone union was achieved more rapidly in the PRP group, which suggests that enhanced bone formation was achieved by providing an elevated concentration of PRP. However, further research is required. In the present study, bone union was achieved more rapidly in the PRP group, which suggests that enhanced bone formation was achieved by providing an elevated concentration of PRP. However, further research is required. Disclosure of Interest None declared