富血小板血浆治疗股骨干缺血萎缩型骨不连:前瞻性随机对照临床试验

Platelet-rich plasma combined with conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures: study protocol for a prospective, randomized, controlled clinical trial

背景:以内外固定联合自体骨植骨治疗缺血萎缩型骨不连治疗周期长,且存在不能治愈情况。富血小板血浆含有多种生长因子以及大量白细胞,有助于促进组织愈合,但尚无其治疗缺血萎缩型骨不连有效性的临床研究。目的:观察富血小板血浆治疗股骨干缺血萎缩型骨不连的有效性。方法:一项正在青海大学附属医院进行的前瞻性开放性随机对照临床试验。招募92例符合标准的股骨干缺血萎缩型骨不连患者,按1∶1比例随机分为对照组和试验组。对照组采用常规手术方法治疗,试验组在常规手术的基础上在患者注射自体富血小板血浆。以术后9个月骨折愈合率为主要结局指标;以静息态和被动运动时的目测类比评分、愈合时间、治疗费用以及不良反应作为次要结局指标。研究方案已于2014-05-20经中国青海大学附属医院伦理委员会批准(批准号QHG0223A)。试验已取得患者的书面知情同意。结果与结论:目前已完成的部分试验结果显示,2组患者术后第1-3天时进行的目测类比评分及并发症情况接近,但试验组骨不连愈合率明显高于对照组,骨不连愈合时间显著短于对照组。试验结果旨在为临床使用富血小板血浆治疗缺血萎缩性骨不连的有效性提供客观数据。

BACKGROUND:Internal and external fixation combined with autologous bone graft for treating atrophic nonunion has a long treatment cycle,and moreover,it cannot achieve a100%cure rate.Platelet-rich plasma contains a variety of growth factors and a large number of white blood cells,and contributes to tissue healing.However,there is no clinical study on the effectiveness of platelet-rich plasma combined with conventional surgery in the treatment of atrophic nonunion.OBJECTIVE:To investigate the effectiveness of platelet-rich plasma in the treatment of atrophic nonunion of femoral shaft fractures.METHODS:We conducted a prospective,open-label,randomized,controlled clinical trial at the Affiliated Hospital of Qinghai University,China.Ninety-two patients with atrophic nonunion of femoral shaft fractures were equally and randomly divided into control group and experimental group.Patients in the control group received conventional surgery.Patients in the experimental group were injected with autologous platelet-rich plasma on the basis of conventional surgery.The primary outcome was fracture healing rate at postoperative9months.The secondary outcomes were visual analogue scale scores in resting state and during passive motion,healing time,treatment costs,and adverse reactions.The study protocol was approved by the Ethics Committee of Affiliated Hospital of Qinghai University of China(approval number:QHG0223A)on May20,2014.Written informed consent was provided by each patient and their family members after they fully understood the treatment plan.RESULTS AND CONCLUSION:Our partial results demonstrated that visual analogue scale scores and complications were similar between the two groups at postoperative1-3days.The healing rate was significantly higher in the experimental group than in the control group.The healing time was significantly shorter in the experimental group than in the control group.This trial will provide objective data for the clinical use of platelet-rich plasma combined with conventional surgery for the treatment of atrophic nonunion.