Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial protocol and pilot study results

doi:10.3969/j.issn.2095-4344.1292

Abstract

Abstract:

BACKGROUND: Anterior cruciate ligament tibial eminence avulsion fractures are repaired via early open reduction. Choosing the best fixation method in accordance with the bone size can effectively promote restoration of the cruciate ligament to its normal anatomical position and achieve bone healing. The use of absorbable screws for internal fixation of anterior cruciate ligament tibial eminence avulsion fractures reportedly promotes fracture healing, but the efficacy and safety need further clarification.

OBJECTIVE: The present study aims to observe the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture.

METHODS: This prospective, single-center, self-controlled trial will include 72 patients with anterior cruciate ligament tibial eminence avulsion fractures. Open reduction and internal fixation with absorbable screws will be performed through a small incision. All patients will be followed up at 3, 6, and 12 months postoperatively. This study was approved by the Medical Ethics Committee of No. 1 Hospital of Longnan City, China in December 2014 (approval number: S2014-064-02). Protocol version is (1.0). Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants’ family members or the participants themselves. This study was registered with the Chinese Clinical Trial Registry on March 13, 2019 (registration number: ChiCTR1900021865).

RESULTS AND CONCLUSION: The primary outcome measure is the recovery of knee function assessed by the Lysholm Knee Scoring Scale score at 12 months postoperatively. Secondary outcome measures are the Lysholm Knee Scoring Scale scores preoperatively and 3 and 6 months postoperatively, the International Knee Documentation Committee scores, knee range of motion, knee morphology on radiographs and MR images preoperatively and 3, 6, and 12 months postoperatively, and the incidences of adverse reactions 3, 6, and 12 months postoperatively. In our pilot study involving 50 patients with anterior cruciate ligament tibial eminence avulsion fractures (50 knees) from October 2015 to January 2018, no patient had joint stiffness or fracture redisplacement on radiography 3 months postoperatively. The mean knee range of motion was significantly larger at 6 months postoperatively compared with preoperatively (P < 0.05). Lysholm Knee Scoring Scale scores and International Knee Documentation Committee scores were significantly improved 6 months postoperatively compared with preoperatively (P < 0.05). This trial will assess the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision to restore knee function in patients with anterior cruciate ligament tibial eminence avulsion fracture.

Key words: anterior cruciate ligament tibial eminence avulsion fracture, open reduction, absorbable screws, internal fixation, Lysholm Knee Scoring Scale score, International Knee Documentation Committee score, self-controlled study

CLC Number:

R459.9|R605

Yang Xiaoguang, Wang Yingzhen.

Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial protocol and pilot study results

[J]. Chinese Journal of Tissue Engineering Research, 2019, 23(24): 3819-3823.

Figures/Tables 2

2.5 预期可能的不良反应 (1)试验主要观察的不良反应包括前交叉韧带胫骨止点撕脱骨折修复后所出现的骨折延迟愈合、感染、周围神经损伤、骨折再移位及膝关节僵硬发生情况。 (2)不良事件报告规定：如果在前交叉韧带胫骨止点撕脱骨折修复后出现后不良事件，报告时限：获知24 h。在临床研究中，不论受试者接受哪种治疗，所发生的任何不良事件，应立即对受试者采取适当的治疗措施。 (3)严重不良事件：如因其他因素所致的胫骨再骨折，或由于不可预见的因素所导致的出血、昏迷和休克的严重不良事件，临床医师必须在发生严重不良事件1 h内向项目负责人和临床试验机构报告并采取对应的应急治疗措施救治。 2.6 小样本50例试验结果 (1)小样本50例患者基线资料：收集2015年10月到2018年1月来陇南市第一人民医院就诊的50例前交叉韧带胫骨止点撕脱骨折患者临床资料作为研究对象，所有患者均经过CT及MRI确诊。本组50例患者Lysholm膝关节评分(Lysholm knee score，LKSS)为(51.43±2.36)分，IKDC评分为(44.36± 2.24)分。男32例，女18例，年龄10-50岁，平均年龄(20.46±2.37)岁，病程1-400 d，平均病程(125.68±3.67)d；运动伤6例；交通事故伤37例，摔伤7例。 (2)小样本患者50例术中情况分析：纳入的50例患者均顺利完成手术，手术时间为(60.23±5.64)min，术中出血量为(56.89±3.68)mL。术后有2例患者出现切口延迟愈合，给予甲钴胺片(博可保，海兰斯达制药有限公司，国药准字H20050997)治疗后1个月后恢复。无切口感染、窦道形成以及神经损伤等并发症发生率。 (3)小样本患者50例术后随访情况分析：纳入的50例患者随访6-40个月，平均随访时间为(30.2±3.6)个月，术后6个月，术前患者膝关节活动度平均为(95.6±5.8)°，术后6个月患者膝关节平均活动度为(132.7±4.5)°，术前术后比较(P=0.000)。且术后患者Lysholm膝关节评分及国际膝关节评分委员会(International Knee Documentation Committee，IKDC)评分均比手术前有所改善，术前术后比较差异有显著性意义(P < 0.05)，见表3，4。 (4)小样本50例患者发生的不良反应及危害：该组患者术后3个月X射线复查患者骨折均愈合均未见关节僵硬和骨折再移位等现象。见表5。"

References

[1]Albtoush OM, Horger M, Springer F, et al. Avulsion fracture of the medial collateral ligament association with Segond fracture. Clin Imaging. 2019;53:32-34.

[2]Yao J, Wang H, Quan S, et al. Suture-bridge fixation under arthroscopy in treatment of tibial eminence avulsion fracture of anterior cruciate ligament in adolescents. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2018;32(11):1402-1405.

[3]Lombardo-Torre M, Espejo-Reina A, García-Gutiérrez G, et al. Arthroscopic treatment of concurrent avulsion fracture of anterior and posterior cruciate ligament with suspension device. J Orthop Case Rep. 2018;8(2):81-85.

[4]Strauss EJ, Kaplan DJ, Weinberg ME, et al. Arthroscopic management of tibial spine avulsion fractures: principles and techniques. J Am Acad Orthop Surg. 2018;26(10):360-367.

[5]Liang X, Tian Y, Wang S, et al. Clinical efficacy of arthroscopic simultaneous treatment for anterior cruciate ligament injury combined with meniscus bucket-handle tear. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2017;31(5):547-552.

[6]Hsieh YL, Yang CC. Early intervention of swimming exercises attenuate articular cartilage destruction in a rat model of anterior cruciate ligament and meniscus knee injuries. Life Sci. 2018;212: 267-274.

[7]Park JY, Jeong BS, Roh YS, et al. Evaluation of an arthroscopic stifle lever for stifle joint distraction in toy breed dogs. J Vet Sci. 2018;19(5): 693-698.

[8]Chmielnicki M, Siebert W, Prokop A. Foreign material-free anterior cruciate ligament repair with hamstring graft, felmet technique. Z Orthop Unfall. 2018;156(2):223-225.

[9]Lombardo-Torre M, Espejo-Reina A, García-Gutiérrez G, et al. Arthroscopic treatment of concurrent avulsion fracture of anterior and posterior cruciate ligament with suspension device. J Orthop Case Rep. 2018;8(2):81-85.

[10]Sekiya H, Takatoku K, Kimura A, et al. Arthroscopic fixation with EndoButton for tibial eminence fractures visualised through a proximal superomedial portal: a surgical technique. J Orthop Surg (Hong Kong). 2016;24(3):417-420.

[11]Sueyoshi T, Emoto G, Yato T. Correlation between single assessment numerical evaluation score and lysholm score in primary total knee arthroplasty patients. Arthroplast Today. 2017; 4(1):99-102.

[12]Kose O, Deniz G, Ozcan H, et al. A comparison of telephone interview versus on-site completion of Lysholm knee score in patients who underwent arthroscopic ACL reconstruction: are the results equivalent? Eur J Orthop Surg Traumatol. 2015;25(6): 1069-1072.

[13]Ra HJ, Kim HS, Choi JY, et al. Comparison of the ceiling effect in the Lysholm score and the IKDC subjective score for assessing functional outcome after ACL reconstruction. Knee. 2014;21(5): 906-910.

[14]Kümmel D, Preiss S, Harder LP, et al. Measurement properties of the German version of the IKDC subjective knee form (IKDC-SKF). J Patient Rep Outcomes. 2018;2:31.

[15]Huang CC, Chen WS, Tsai MW, et al. Comparing the Chinese versions of two knee-specific questionnaires (IKDC and KOOS): reliability, validity, and responsiveness. Health Qual Life Outcomes. 2017;15(1):238.

[16]Dietvorst M, Reijman M, van Groningen B, et al. PROMs in paediatric knee ligament injury: use the Pedi-IKDC and avoid using adult PROMs. Knee Surg Sports Traumatol Arthrosc. 2017. DOI: 10.1007/s00167-017-4687-3.

[17]Tigerstrand Grevnerts H, Grävare Silbernagel K, Sonesson S, et al. Translation and testing of measurement properties of the Swedish version of the IKDC subjective knee form. Scand J Med Sci Sports. 2017;27(5):554-562.