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经Hardinge入路行全髋关节置换术中围手术期富血小板血浆(PRP):研究对臀中肌愈合有效性的方案

Perioperative platelet rich plasma (PRP) in total hip arthroplasty through the Hardinge approach: protocol to study the effectiveness for gluteus medius healing.

作者信息

Aavikko Anni, Puhakka J, Haapala J, Kukkonen J, Mäkelä K, Kosola J

机构信息

Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.

Department of Surgery, Satakunta Central Hospital, Pori, Finland.

出版信息

J Exp Orthop. 2018 Jun 19;5(1):23. doi: 10.1186/s40634-018-0127-7.

Abstract

BACKGROUND

Platelet-rich plasma (PRP) has been used to support tendon regeneration mainly in sports medicine. PRP is a concentrate of platelet-rich plasma proteins derived from whole blood by centrifugation to remove erythrocytes and leukocytes. PRP has high amounts of platelets which may promote healing tendons affected by degenerative conditions. These platelets contain growth factors and are known to facilitate the regeneration of injured tendon structures. Total hip arthroplasty (THA) through the Hardinge approach may leave the patient with impaired gait and poor regeneration of the gluteus medius tendon if the tendon is not reattached properly after closure of the surgical wound.

METHODS

The study will be a multicenter, double-blinded and randomized study enrolling 90 patients based on power calculations. The efficacy of perioperative PRP treatment will be assessed by subjective and objective outcome variables. The participants will be randomized (sealed envelope) into either a placebo (saline) or a PRP group (1:1). For subjective outcomes, the Oxford Hip Score (OHS) will be collected before surgery and 3 and 12 months after surgery. The objective measures are findings at magnetic resonance imaging and plain radiographs and recorded values of measured strength.

DISCUSSION

We present the perioperative use and the ways to measure the clinical efficacy of PRP. As PRP may have benefits regarding degenerative tendon regeneration, studies on the use of PRP in hip arthroplasty are warranted to facilitate postoperative recovery.

TRIAL REGISTRATION

This study has been approved by the ethics committee of the Hospital District of Southwest Finland and approved by the local institutional research board. The study has been registered in ClinicalTrials.gov ( NCT02607462 ).

摘要

背景

富含血小板血浆(PRP)主要用于运动医学领域以支持肌腱再生。PRP是通过离心全血去除红细胞和白细胞后得到的富含血小板血浆蛋白浓缩物。PRP含有大量血小板,可能促进受退行性病变影响的肌腱愈合。这些血小板含有生长因子,已知可促进受损肌腱结构的再生。如果在手术伤口闭合后臀中肌腱未正确重新附着,通过Hardinge入路进行全髋关节置换术(THA)可能会使患者步态受损且臀中肌腱再生不良。

方法

该研究将是一项多中心、双盲随机研究,根据功效计算招募90名患者。围手术期PRP治疗的疗效将通过主观和客观结果变量进行评估。参与者将被随机(密封信封)分为安慰剂(生理盐水)组或PRP组(1:1)。对于主观结果,将在手术前以及手术后3个月和12个月收集牛津髋关节评分(OHS)。客观测量指标为磁共振成像和X线平片检查结果以及测量力量的记录值。

讨论

我们介绍了PRP的围手术期使用方法及其临床疗效的测量方法。由于PRP在退行性肌腱再生方面可能有益处,因此有必要开展关于PRP在髋关节置换术中应用的研究,以促进术后恢复。

试验注册

本研究已获得芬兰西南部医院区伦理委员会的批准,并得到当地机构研究委员会的认可。该研究已在ClinicalTrials.gov(NCT02607462)注册。

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