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一项评估测量式客观张力装置在腘绳肌前交叉韧带重建中临床有效性的随机临床试验。

A Randomized Clinical Trial to Assess the Clinical Effectiveness of a Measured Objective Tensioning Device in Hamstring Anterior Cruciate Ligament Reconstruction.

作者信息

Grunau Peter David, Arneja Shalinder, Leith Jordan Michael

机构信息

Department of Orthopaedics, University of British Columbia, Vancouver, British Columbia, Canada

Department of Orthopaedics, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

Am J Sports Med. 2016 Jun;44(6):1482-6. doi: 10.1177/0363546516634021. Epub 2016 Mar 15.

DOI:10.1177/0363546516634021
PMID:26980844
Abstract

BACKGROUND

Soft tissue grafts are commonly used in surgical reconstruction of the anterior cruciate ligament (ACL). Applying the appropriate tension to the final graft reconstruction has traditionally been performed by the surgeon and is based on the surgeon's experience and perception of applied tension. Problems with manual application of tension to the ACL reconstruction include under- or overtightening the reconstruction, inconsistent tension application among subjects, and variable load application to each strand.

PURPOSE

To assess whether measured tensioning of hamstring ACL grafts during fixation improves clinical outcome or knee laxity postoperatively when compared with conventional tensioning maneuvers.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

This was a prospective randomized controlled trial of consecutive primary ACL patients. The device group included patients in whom a measured tensioning device was used for graft tensioning (80 N), and the physician group did not use a tensioning device. The primary outcome was KT-1000 arthrometer side-to-side laxity differences between knees at 6, 12, and 18 months postoperatively. Secondary outcomes included the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form and Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QoL) at those intervals. Chi-square and t tests were used for analysis. The study had 90% power to detect a difference of 2 mm between groups.

RESULTS

A sample of 127 patients was randomized. Of those, 14 did not have follow-up data and were excluded from this analysis, resulting in a final sample of 113 (55 patients in the device group and 58 in the physician group). No significant differences were found in baseline demographics or comorbidities. There were no significant differences between the groups (physician vs device) at baseline and at 6, 12, and 18 months in side-to-side laxity (4.6 vs 4.7 mm, 1.6 vs 1.3 mm, 1.5 vs 1.3 mm, and 1.1 vs 1.0 mm, respectively), IKDC score (58.2 vs 56.4, 72.0 vs 67.9, 79.9 vs 76.0, and 81.3 vs 78.5, respectively), or ACL-QoL score (998.2 vs 901.2, 1846.4 vs 1647.5, 2150.4 vs 2268.3, and 2436.9 vs 2231.8, respectively).

CONCLUSION

Measured tensioning of hamstring ACL grafts during fixation does not improve clinical outcome or knee laxity postoperatively when compared with conventional tensioning maneuvers.

摘要

背景

软组织移植物常用于前交叉韧带(ACL)的手术重建。传统上,外科医生会根据自身经验和对施加张力的感知,对最终的移植物重建施加适当的张力。手动对ACL重建施加张力存在的问题包括重建过松或过紧、不同受试者之间的张力施加不一致以及对每一股的负荷施加变化。

目的

评估与传统张力调整操作相比,在固定过程中对腘绳肌ACL移植物进行测量张力调整是否能改善术后临床结果或膝关节松弛度。

研究设计

随机对照试验;证据等级,1级。

方法

这是一项对连续的原发性ACL患者进行的前瞻性随机对照试验。器械组包括使用测量张力装置(80 N)对移植物进行张力调整的患者,医生组未使用张力调整装置。主要结局是术后6个月、12个月和18个月时膝关节之间的KT - 1000关节测量仪侧方松弛度差异。次要结局包括这些时间点的国际膝关节文献委员会(IKDC)主观膝关节评估表和前交叉韧带生活质量问卷(ACL - QoL)。采用卡方检验和t检验进行分析。该研究有90%的把握度检测出组间2 mm的差异。

结果

127例患者被随机分组。其中,14例没有随访数据,被排除在本分析之外,最终样本为113例(器械组55例,医生组58例)。在基线人口统计学或合并症方面未发现显著差异。在基线以及术后6个月、12个月和18个月时,组间(医生组与器械组)在侧方松弛度(分别为4.6 vs 4.7 mm、1.6 vs 1.3 mm、1.5 vs 1.3 mm和1.1 vs 1.0 mm)、IKDC评分(分别为58.2 vs 56.4、72.0 vs 67.9、79.9 vs 7

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