Efficacy and safety of longitudinal approach versus tarsal sinus approach for treating displaced intra-articular calcaneal fractures

doi:10.3969/j.issn.2095-4344.2017.35.014

Abstract

Abstract:

BACKGROUND: The key point of the displaced intra-articular calcaneal fractures is to accurately and effectively reset the intra-articular calcaneal fractures and effectively reduce the incidence of incision-related complications. Currently, the minimally invasive approach has been widely used in the treatment of calcaneal fractures.

OBJECTIVE: To compare the clinical outcomes and safety of minimally invasive longitudinal approach and minimally invasive tarsal sinus approach for displaced intra-articular calcaneal fractures.

METHODS: A prospective, single center, open-label, randomized, controlled clinical trial is conducted. 200 patients with displaced intra-articular calcaneal fractures will be randomly divided into minimally invasive approach group and tarsal sinus approach group, with 100 cases in each group, and treated with minimally invasive longitudinal approach and tarsal sinus approach repair, respectively. Follow-up time will be 5 weeks, 4, 8, 12, 36 months after surgery. The primary outcome is the excellent and good rate of American Orthopaedic Foot and Ankle Society score at 5 weeks, 4, 8, 12 and 36 months after operation. Secondary outcomes are operative time, CT and X-ray images preoperatively and 5 weeks, 4, 8, 12, 36 months postoperatively at the injury site, and the incidence of adverse reactions 5 weeks, 4, 8, 12, 36 months postoperatively. The trial has been approved by Ethics Committee of Wuxi Third People's Hospital. The study is in line with the Declaration of Helsinki developed by the World Medical Association. Participants will be informed and sign consent for the protocol and procedure. Trial ethics approval [Approved by: Wuxi Third People's Hospital, Approval No. 20140402-2] was conducted in April 2014. The sample and data collection will be from January 2018 to October 2019, and the indicator analysis time and test completion time will be December 2019. The results will be reported in scientific meetings or published in peer-reviewed journals. The trial has registered in China Clinical Trial Register (registration number: ChiCTR-IOR-17013697).

DISCUSSION: The trial will compare minimally invasive tarsal sinus approach and minimally invasive longitudinal approach for the treatment of displaced intra-articular calcaneal fractures to clarify the characteristics and clinical application range of the two minimally invasive techniques.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Calcaneus, Fractures, Bone

CLC Number:

R318

Zhang Bin, Yang Xiao-fei, Yang Zhi-gang, Chen Jing, Hua Jiao, Yuan Feng-lai . Efficacy and safety of longitudinal approach versus tarsal sinus approach for treating displaced intra-articular calcaneal fractures[J]. Chinese Journal of Tissue Engineering Research, 2017, 21(35): 5661-5667.

Figures/Tables 1

稿件提交时已获得124例患者的预实验结果如下： 2.1 基线资料分析见表3。 2.2 软组织并发症情况分析通过对患者的切口软组织并发症调查发现(表4)，手术切口愈合并发症13例。其中，浅表感染8例(跗骨窦微创入路组5例，纵行微创入路组3例)；跗骨窦微创入路组患者中发现有3例深部感染和2例皮缘感染。8例浅表感染患者通过换药治疗后痊愈。腓肠神经损伤跗骨窦微创入路组3例、纵行微创入路组2例，差异无显著性意义(P > 0.05)。在足底内侧神经损伤及拇长屈肌肌腱损伤方面，跗骨窦微创入路组4例，纵行微创入路组5例，差异无显著性意义(P > 0.05)。试验中，跗骨窦微创入路组4例和纵行微创入路组3例由于并发症提前取出内固定物外。 2.3 术前与术后影像学分析通过对试验中患者术前与术后影像学分析发现：术前Böhler角跗骨窦微创入路组为2.0°(-46°-21°)，纵行微创入路组为-1.4°(-49°-25°)。术后Böhler角跗骨窦微创入路组为25.8°(13°-56°)，纵行微创入路组为28.5°(12°-54°)(P > 0.05)。在术后的随访过程中并没有发现Böhler角的明显变化。根据术后即刻CT影像测量发现，两组患者术后复位质量对于SandersⅡ/Ⅲ型跟骨骨折差异无显著性意义(P > 0.05)，然而对于Ⅳ型骨折跗骨窦微创入路组复位质量明显优于较纵行微创入路组(P < 0.05；表5)。术后开始早期部分负重锻炼的时间跗骨窦微创入路组平均为5.5周(4-9周)，纵行微创入路组平均为5.1周(4-9周)，两组之间差异无显著性意义(P > 0.05)。通过术后第4个月的CT影像检查，没有发现明显的跟骨增宽及复位丢失等迹象。此外，所有患者也没有出现外踝疼痛等症状。 2.4 AOFAS评分结果跗骨窦微创入路组AOFAS评分为优的有38例(60.3%)，为良的有12例(19.0%)，为可的有10例(15.9%)，为差的有3例(4.8%)；AOFAS评分为优的有纵行微创入路组35例(57.4%)，为良的有14例(22.9%)，为可的有8例(13.1%)，为差的有4例(6.6%)。两组平均AOFAS评分，跗骨窦微创入路组为85.2分，纵行微创入路组为87.5分，两组差异无显著性意义(P > 0.05)。在4项AOFAS的主观评分中，跗骨窦微创入路组均高于纵行微创入路组，但差异不显著；而行走路面一项两组间AOFAS评分差异有显著性意义(P < 0.05；表6)。根据Sanders分型分析患者在术后评分的差异发现：跗骨窦微创入路组患者取得优良评分的，Ⅱ型29例、Ⅲ型22例、Ⅳ型7例；纵行微创入路组患者取得优良评分的，Ⅱ型30例、Ⅲ型18例、Ⅳ型2例。两组患者术后功能对于SandersⅡ/Ⅲ型跟骨骨折无显著差异(P > 0.05；表7)，然而对于Ⅳ型骨折跗骨窦微创入路组功能评分优良率高于纵行微创入路组(P < 0.05)。"

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