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Effects of Platelet Rich Plasma on Healing Rate of Long Bone Non-union Fractures: A Randomized Double-Blind Placebo Controlled Clinical Trial

机译:富血小板血浆对长骨不愈合骨折愈合率的影响:随机双盲安慰剂对照临床试验

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Objective: To determine the effects of platelet rich plasma PRP on healing rates of long bone non-union fracture. Method: This was a randomized double-blind placebo controlled clinical trial being performed in a 12-month period. We included 75 adult (&18 years) patients suffering from long bone (Femur, Tibia, Humerus and Ulna) non-union fracture who were randomly assigned to receive 5mL PRP (n=37) or 5mL normal saline as placebo (n=38) in the site of fracture after intramedullary nailing or open reduction and internal fixation (ORIF) along with autologous bone graft. Patients were followed each 45 days till 9 months and were evaluated both clinically and radiologically in each visit. The healing rate, failure rate, incidence of infection, mal-union and limb shortening were recorded and compared between groups after 9 months of follow-up. Results: The healing rate was significantly higher in PRP group compared to placebo (81.1% vs. 55.3%; p=0.025 ). The limb shortening was significantly higher in those who received placebo (2.61?±1.5 vs. 1.88?±1.2mm; p=0.030 ). Injection of PRP was also associated with lower pain scores ( p=0.003 ) and shorter healing duration ( p=0.046 ). The surgical site infection ( p=0.262 ) and mal-union rate ( p=0.736 ) were comparable between groups. Conclusion: Application of PRP along with autologous bone graft in the site of non-union of long bone after intramedullary nailing or ORIF results in higher cure rate, shorter healing duration, lower limb shortening and less postoperative pain. Higher infection rate might be a complication of PRP application. Keywords: Non-union; Long bone Fracture; Platelet rich plasma (PRP); Intramedullary nailing; Open reduction and internal fixation (ORIF). Clinical Trial Registry: This trial is registered with the Iranian Clinical Trials Registry (IRCT201208262445N1; www.irct.ir ).
机译:目的:确定富含血小板的血浆PRP对长骨不愈合骨折愈合率的影响。方法:这是一项为期12个月的随机双盲安慰剂对照临床试验。我们纳入了75名成年(> 18岁)患有长骨(股骨,胫骨,肱骨和尺骨)不愈合骨折的成人患者(≥18岁),他们随机分配接受5mL PRP(n = 37)或5mL生理盐水作为安慰剂(n = 38)在髓内钉或切开复位内固定(ORIF)以及自体骨移植后的骨折部位。每45天随访一次,直至9个月,并在每次就诊时对患者进行临床和放射学评估。记录9个月的随访情况,比较两组的愈合率,失败率,感染发生率,畸形和肢体缩短情况。结果:与安慰剂相比,PRP组的治愈率显着更高(81.1%对55.3%; p = 0.025)。接受安慰剂的患者的肢体缩短明显更高(2.61±1.5,1.88±1.2mm; p = 0.030)。注射PRP还与较低的疼痛评分(p = 0.003)和较短的愈合时间(p = 0.046)相关。两组之间的手术部位感染(p = 0.262)和骨不合率(p = 0.736)相当。结论:在髓内钉或ORIF术后,在长骨不愈合的部位应用PRP结合自体骨移植可提高治愈率,缩短愈合时间,缩短下肢缩短,减轻术后疼痛。较高的感染率可能是PRP应用的并发症。关键字:不工会;长骨骨折;富血小板血浆(PRP);髓内钉;切开复位和内固定(ORIF)。临床试验注册中心:该试验已在伊朗临床试验注册中心(IRCT201208262445N1; www.irct.ir)注册。

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