【作者】 王琳；

【导师】 崔慧先； 张英泽；

【作者基本信息】 河北医科大学 ， 人体解剖与组织胚胎学， 2014， 博士

【摘要】 借助韧带包绕、连结胫骨远端外侧和外踝上方的腓骨内侧，形成下胫腓联合，这是维持踝关节稳定性的重要结构。踝关节损伤常合并下胫腓联合损伤，原有的踝关节结构也随之改变。若治疗不当，未能及时、有效地复位下胫腓联合并恢复其原有的微动功能，则可能产生踝关节不稳定、慢性疼痛、踝关节功能退化和创伤性关节炎等问题。诸多学者对下胫腓联合的结构和功能，以及损伤后的治疗不断地进行研究和探讨，设计了多种内固定装置。本研究也对下胫腓联合损伤的内固定技术和内固定装置进行了创新，改进了下胫腓联合损伤手术中内固定的置入角度，本研究的第一部分，为这一改进提供解剖学理论支持。本研究还将螺栓和Suture-button技术相结合，设计了“仿生弹性固定装置”。利用这种内固定装置，即可在有效固定下胫腓联合的同时，最大限度保留其原有微动功能。本实验的第二部分，分别将仿生弹性固定装置、皮质骨螺钉、双Endo-button钢板固定的下胫腓联合，与完整下胫腓联合进行了生物力学实验，比较各种固定装置的生物力学性能，以期为仿生弹性固定装置的临床应用，提供生物力学方面的实验依据。本研究的第三部分，评价应用改进技术和装置治疗下胫腓联合损伤的功能结果，为其有效性提供临床证据。第一部分下胫腓联合的临床解剖学研究目的：通过对下胫腓联合的临床解剖学研究，分析下胫腓联合的结构特点，为改进临床手术方法提供解剖学依据。方法：选择6只新鲜成年尸体下胫腓联合标本，对其进行层次解剖显露下胫腓联合各韧带后，用分规和精度为0.02mm的游标卡尺测量下胫腓前、后韧带的长度（上缘和下缘）和宽度；用克氏针和量角器测量下胫腓前、后韧带长轴与冠状面和踝关节面成的角度。结果：下胫腓前韧带近端长度为8.12±0.65mm，远端长度为19.78±1.69mm，宽度为17.45±1.30mm，与冠状面夹角为24°±5°，与胫骨踝关节面夹角为31°±4°。下胫腓后韧带近端长度为9.77±0.90mm，远端长度为20.35±2.33mm，宽度为18.58±1.63mm，与冠状面夹角为14°±3°，与胫骨踝关节面夹角为18°±2°。结论：下胫腓联合属于胫腓骨远端的韧带连结，由下胫腓前、后韧带和骨间韧带维持其稳定性。固定下胫腓联合的内固定装置，若以从后外向前内且内侧轻度抬高的方向置入，则更为符合下胫腓联合的原有生理状态。第二部分仿生弹性固定装置、螺钉和双Endo-button钢板内固定治疗下胫腓联合损伤的生物力学比较研究目的：通过生物力学实验比较不同方式（皮质骨螺钉、仿生弹性固定装置、双Endo-button钢板）固定后的下胫腓联合和未破坏的下胫腓联合之间在稳定性上的区别。为仿生弹性固定装置这一创新内固定装置的临床应用，以及术后早期康复活动提供理论支持。方法：选择6例新鲜成年人小腿足踝尸体标本，切断下胫腓前、后韧带和骨间韧带制作下胫腓联合损伤模型。将下胫腓联合复位后分别使用直径3.5mm皮质骨螺钉、仿生弹性固定装置和双Endo-button钢板经相同入路固定（钉道由腓骨后外斜向胫骨前内，与冠状面夹角25°～30°，胫侧抬高10°～15°）。将标本固定于Bose ElectroForce3520-AT生物力学机上，胫腓骨远端粘贴应变片，在踝关节处于不同位置（中立位、背伸位、跖屈位、内翻位、外翻位）时，对标本加载0～700N的载荷。测量胫、腓骨间的位移变化和胫、腓骨的应变变化。在中立位300N载荷下，内旋或外旋踝关节，施加0～5Nm的扭距，测量位移变化和应变变化。将原始标本和3种内固定标本的数据结果进行两两比较，采用随机区组设计的方差分析，有统计学意义后用Student-Newman-Keuls（SNK）法进一步做两两比较，P＜0.05为差异有统计学意义，所有数据用SPSS16.0统计软件分析。结果：无论标本加载载荷或者扭矩时，螺钉固定组产生位移数值最小，并且在绝大多数情况下（中立位、背伸位、内翻位、跖屈位的低载荷、外翻位的高载荷和内、外旋），这种分别小于其他3组的差异是有统计学意义的（P<0.05）。尽管仿生固定组和双Endo-button固定组产生的位移数值大小相当，且略大于原始标本组（极个别记录点例外），但是这3组间的差异分析后几乎都没有统计学意义（P>0.05）。置入内固定装置后，胫骨的应变变化幅度减小（扭转-外旋时例外），而螺钉固定组的减小最明显（除去压力的中立位和背伸位以外，差异都有统计学意义）。仿生固定组和双Endo-button钢板组之间差异不大，而腓骨上的应变几乎没有出现有统计学意义的变化。结论：穿过4层皮质的螺钉固定，阻碍下胫腓联合微动。对下胫腓联合损伤行手术治疗时，应采用更接近生理需求的仿生弹性固定装置进行固定，在获得稳定固定的同时，保留下胫腓联合本身微动功能，以利患者早期踝关节康复训练，促进其功能恢复，减少术后并发症的产生，提高预后。第三部分仿生弹性固定装置治疗下胫腓联合损伤的临床观察目的：本研究旨在评价利用仿生弹性固定装置，治疗下胫腓联合损伤的临床疗效。方法：2013年6月至2014年1月，对12例下胫腓联合损伤患者应用仿生弹性固定装置治疗。其中男7例，女5例；左4例，右8例；年龄15～58岁，平均37.2±12.3岁。按照踝关节骨折Danis-Weber分型，其中B型5例、C型7例（C1型4例，C2型3例）。按照Lauge-Hansen分型，旋前外旋型4例、旋前外展型3例、旋后外旋型5例。所有患者均将仿生弹性固定装置按自腓骨后外向胫骨前内，胫侧轻度抬高方向置入，与冠状面夹角25°～30°，与踝关节面夹角10°～15°。术后24小时，患者即进行踝关节屈伸锻炼。结果：本组中全部患者获得随访，平均6.5个月（5～9个月）。1例术后8周骨折愈合，11例术后12周愈合。1例术后8周即完全负重锻炼，10例术后12周完全负重活动，1例因肢体其他部位骨折未愈合，延迟负重锻炼。患者术后随访X线检查均未发现仿生弹性固定装置线缆断裂现象，下胫腓联合处胫腓间隙及踝穴与术后X线片无明显变化，无关节退变和关节炎征象，也未观察到腓侧固定扣或胫侧螺母位置骨质变化。术后（9例6个月，3例5个月）AOFAS踝-后足功能评分：优8例，良3例，一般1例。结论：应用仿生弹性固定装置，可实现下胫腓联合稳定可靠的弹性固定，患者术后踝关节功能恢复良好，并发症较少，是治疗所有类型下胫腓联合损伤的理想方法。更多还原

【Abstract】 The incisura fibularis connects the medial surface in lowerpart of fibula by ligament fiber to form distal tibiofibular syndesmosis,functioning as an important structure to maintain the stability of the anklejoint. The original structure of ankle joint is changed when the distaltibiofibular syndesmosis is ruptured that often associated with the anklejoint injury. If the treatment for the distal tibiofibular syndesmosis injuryis inappropiate and not able to restore the alignment and function ofsyndesmosis, sequelae as instability, chronic pain, functional deteriorationand traumatic arthritis may will be inevitable. Researchers continuouslymake efforts to improve clinical outcomes of distal tibiofibularsyndesmosis injuries， and designed a variety of internal fixation device.We have made innovations in the fields of the hole preparation methodfor internal fixation device in ORIF. We have modified the angle ofdevice placement in ORIF for syndesmosis. The first part of this researchaim to provide anatomical evidences to back up the clinical usage of thisnew technique. We also have designed a new internal fixation devicecalled “Bionic elastic fixing device”, which is combined with the boltsand Suture-button system. This device can be effective in fixing thesyndesmosis and maximally retains its original function. In the secondpart of the study，biomechanical properties of intact syndesmosis andinjury model fixed with different divices were performed and compareseparately. Result will show which one is the best for syndesmosis.Clinical study was then carried out to prove the effectiveness of thisfixation method and fixing divice. Part1Clinical anatomical observation of the distal tibiofibularsyndesmosisObjective: To analyze the Structural characteristics of the distaltibiofibular syndesmosis and improve the operation method through theanatomic investigation of the complex ligament of distal tibiofibularsyndesmosis.Methods:6adult lower legs of frozen-fresh specimens were selected.The anterior tibiofibular ligament (ATFL) and posterior tibiofibularligament (PTFL) were carefully observed. The process coruse and therelationships to each others were carefully observed, the preciseanatomical parameters (length, width) of ATFL and PTFL were alsomeasured by divider and vernier caliper (the accuracy of0.02mm).Using Kirschner wires and a protractor measure the angle between eachligament and the coronal plane, and the articular surface of the ankle.Results: In six cases, the average length of upper part of ATFL is8.12±0.65mm, length of lower part19.78±1.69mm, width of ATFL17.45±1.30mm.The average angle between ATFL and Coronal plane is24°±5°, ATFL and ankle joint surface angle is31°±4°. The average lengthof upper part of PTFL is9.77±0.90mm, length of lower part20.35±2.33mm, width of PTFL18.58±1.63mm. The average anglebetween PTFL and Coronal plane is14°±3°, PTFL and ankle joint surfaceangle is18°±2°.Conclusion: Its is by ATFL, PTFL and interosseous ligament (IL)maintained the stability of distal tibiofibular syndesmosis. Fixing deviceis placed from posterolateral fibula to anteromedial tibia. And the medialpart is raised slightly.Part2Biomechanical comparative study on cortical serew, bionicelastic fixing device and double Endo-button system in the treatmentof distal tibiofibular syndesmosis ruptureObjective: To investigate the stability of fixation with3differentinternal fixation devices and intact syndesmosis through thisbiomechanical comparison, with an aim to provide scientific evidence for the clinical use of bionic elastic fixing device on distal tibiofibularsyndesmosis rupture.Methods: Six specimens of frozen-fresh adult cadaveric lower legswere used for analysis. To simulate the clinical injury of the distaltibiofibular syndesmosis by cutting the ligament of the distal tibiofibularsyndesmosis in6cadaveric specimens. We use three type of internalfixation devices by which the injury model was fixed:(1) φ3.5mmcortical serew,(2) bionic elastic fixing device, and (3) doubleEndo-button system. All the holes for placing fixing devices have a samedirection (from posterolateral fibula to anteromedial tibia, coronal angleof25°～30°, tibial elevation10°～15°). The proximal tibia isconnected to the motion unit of Bose ElectroForce3520-AT testingmachine. The strain gages were sticked to distal tibiofibular bone. Wheneach samples’ ankle joint is placed in neutral position, dorsiflexion (10°),plantar flexion (15°), varus (10°), and valgus (15°), we load slowlythe axial force from0to700N, record the displacement of syndesmosisand strain changes of tibia and fibula. In the neutral position and300Nload on each samples’ ankle joint, we give internal and external rotationtorque from0to5Nm, then record the changes. Statistical analysis wasperformed using variance analysis of the randomized block design andSNK test.Results: Whether the specimen bearing load or torque, screwfixation group produced the smallest displacement values, and in mostcases (neutral position, dorsiflexion, varus, plantar flexion of the low load,high load on valgus position, internal and external rotation), were lessthan the other3groups (P<0.05). Although bionic fixed group and doubleEndo-button fixation group get considerable number of displacement, andslightly larger than the intact sample (only very few exceptions), thedifference between them are almost no statistical significance (P>0.05).After fixation, the magnitude of strain changing decreases on tibia(excluding external rotation in twist test), while screw fixation group reducing is most obvious (there are significant differences, excluding theneutral position and dorsiflexion in load test). There are no differencebetween the bionic fixation group and double Endo-button plate group,while the strain on the fibula almost did not change significantly.Conclusion: Fixation with screws through four layers of corticalhinders syndesmosis motion. In the distal tibiofibular syndesmosis injuryoperation, we should choose the bionic elastic fixing device which iscloser to physiological needs for fixation. This device can stably fixsyndesmosis, while retain the motion function of syndesmosis. It isbeneficial to patients with early ankle rehabilitation, promote the functionrecovery, reduce the complications and improve the prognosis.Part3Treatment with bionic elastic fixing device in distal tibiofibularsyndesmosis injuryObjective: To evaluate the clinical and radiological outcomes ofbionic elastic fixing device.Methods: Between June2013and January2014,12patients whohad distal tibiofibular syndesmosis injury were treated with bionic elasticfixing device, included7males and5females, who were aged15to58years old with a mean age37.2±12.3. According to Danis-Weberclassification,5cases of B type, C type in7cases (4type C1,3type C2).According to Lauge-Hansen classification,4cases of Pronation-Eversion,3cases of Pronation-Abduction,5cases of Supination-Eversion. Allpatients were fixed with the bionic elastic fixation device in the same way(from posterolateral fibula to anteromedial tibia, coronal angle of25°～30°, tibial elevation10°～15°).Results: All of them were followed up for5～9months(mean6.5months). Radiological follow-up found1cases healed on8weeks and11cases on12weeks. One patient had full weight-bearing exercise at8weeks after operation,10patients after12weeks. Only one patient haddelayed weight-bearing exercise, as nonunion in other parts of the body.No fixation failure was observed. No joint degeneration, no arthritis signs and no osteolysis was found at radiological follow-up. According toAOFAS score system,8cases were excellent in,3cases were good and1case in general.Conclusion: Bionic elastic fixation device can ensure the stability ofthe ankle joint after surgery. It is demonstrated that bionic elastic fixationdevice for ankle fracture with tibiofibular syndesmosis injury couldrecover the normal motion function and reduce the recovery time, it couldalso avoid the breakage of internal fixation and other complications.更多还原