新型固定支撑接骨板对胫骨平台后交叉韧带附着点撕脱骨折修复的稳定性作用:前瞻性、开放性、自身对照临床试验

发布时间：2018-10-11 20:03

【摘要】：背景:以往研究显示,膝关节后交叉韧带胫骨止点撕脱骨折采用切开复位铆钉固定、空心螺钉固定或采用关节镜下后交叉韧带重建,忽略了后交叉韧带早期张力重建的重要性,因此疗效并不确定。目前在胫骨平台后交叉韧带附着点撕脱骨折固定方法的选择及如何恢复关节的解剖学稳定性问题上尚存在争议。目的:观察新型固定支撑接骨板对胫骨平台后交叉韧带附着点撕脱骨折修复的稳定性作用。方法/设计:研究为前瞻性、单中心、自身对照的临床试验,在中国河北省,沧州市中心医院完成。对纳入试验20例膝关节后交叉韧带胫骨止点撕脱骨折患者经后侧入路暴露骨折断端及损伤的后交叉韧带,直视下行骨折复位,采用新型支撑接骨板固定骨折断端,重建后交叉韧带。固定后随访3,12个月。主要观察指标为固定前、固定后3,12个月的膝关节HSS评分评估固定后患者膝关节功能恢复情况;试验的次要观察指标为固定前、固定后3,12个月Lysholm膝关节评分,X射线,以CT,磁共振检查评估损伤膝关节修复后形态,以及固定后3,12个月患者满意度。试验在北美临床试验注册中心注册(NCT03059368)。试验经中国河北省沧州市中心医院伦理委员会批准。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对治疗方案和过程均知情同意,并签署知情同意书。讨论:试验设计了一种有利于后交叉韧带早期张力重建的新型固定支撑接骨板固定方法,以此修复胫膝关节后交叉韧带胫骨止点撕脱骨折,以期最大限度的恢复膝关节解剖学稳定性,并验证其疗效,从而为膝关节后交叉韧带胫骨止点撕脱骨折治疗提供一定的试验依据,为解决最大限度的恢复膝关节解剖学稳定提供一种途径。
[Abstract]:Background: previous studies have shown that the posterior cruciate ligament tibial avulsion fracture of the knee is fixed by open reduction and rivet fixation, hollow screw fixation or arthroscopic posterior cruciate ligament reconstruction, neglecting the importance of early tension reconstruction of posterior cruciate ligament. The efficacy is therefore uncertain. At present, the choice of fixation method and how to restore the anatomical stability of tibial plateau posterior cruciate ligament attachment point avulsion fracture are still controversial. Aim: to observe the stability of a new fixation plate for the repair of avulsion fracture of posterior cruciate ligament attachment point of tibial plateau. Methods / Design: the study was carried out in a prospective, single center, self-controlled clinical trial at Cangzhou Central Hospital, Hebei Province, China. Twenty cases of tibial avulsion fracture of posterior cruciate ligament of knee joint were exposed through posterior approach to the fracture and the injured posterior cruciate ligament. The fracture was reduced directly and the fracture was fixed with a new type of supporting plate. Reconstruction of posterior cruciate ligament. All patients were followed up for 3 and 12 months after fixation. The main outcome measures were HSS score of knee joint before fixation, 3 months after fixation and 12 months after fixation. The main indexes of the experiment were Lysholm knee joint score before fixation, 3 months and 12 months after fixation, X ray, and Lysholm score before fixation, 3 months and 12 months after fixation, respectively. CT, magnetic resonance imaging was used to evaluate the post-repair morphology of the injured knee joint and the satisfaction of the patients 3 and 12 months after fixation. The trial is registered with the North American Clinical trial Registry (NCT03059368). The test was approved by the Central Hospital Ethics Committee of Cangzhou City, Hebei Province, China. The study meets the requirements of the Helsinki Declaration formulated by the World Medical Association. Participants themselves have informed consent and signed informed consent to the treatment plan and procedure. Discussion: a new fixation supporting plate fixation method was designed to repair tibial avulsion fracture of posterior cruciate ligament in the early stage of posterior cruciate ligament tension reconstruction. In order to restore the anatomical stability of the knee joint to the maximum extent and verify its curative effect, it can provide a certain experimental basis for the treatment of the tibial avulsion fracture of the posterior cruciate ligament of the knee. In order to solve the maximum restoration of anatomical stability of the knee joint provides a way.
【作者单位】：沧州市中心医院;泊头市中心医院;
【分类号】：R687.3

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