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骨传导支架置于腘绳肌腱前交叉韧带重建术中股骨隧道开口处:一项随机对照试验

Osteoconductive Scaffold Placed at the Femoral Tunnel Aperture in Hamstring Tendon ACL Reconstruction: A Randomized Controlled Trial.

作者信息

Götschi Tobias, Hodel Sandro, Kühne Nathalie, Bachmann Elias, Li Xiang, Zimmermann Stefan M, Snedeker Jess G, Fucentese Sandro F

机构信息

Department of Orthopaedics, Balgrist University Hospital, University of Zurich, Zurich, Switzerland.

Institute for Biomechanics, ETH Zurich, Zurich, Switzerland.

出版信息

Orthop J Sports Med. 2023 Jun 5;11(6):23259671231174478. doi: 10.1177/23259671231174478. eCollection 2023 Jun.

DOI:10.1177/23259671231174478
PMID:37347015
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10280525/
Abstract

BACKGROUND

Bone tunnel enlargement after single-bundle anterior cruciate ligament reconstruction remains an unsolved problem that complicates revision surgery.

HYPOTHESIS

Positioning of an osteoconductive scaffold at the femoral tunnel aperture improves graft-to-bone incorporation and thereby decreases bone tunnel widening.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

In a 1:1 ratio, 56 patients undergoing primary anterior cruciate ligament reconstruction were randomized to receive femoral fixation with cortical suspension fixation and secondary press-fit fixation at the tunnel aperture of the tendon graft only (control) or with augmentation by an osteoconductive scaffold (intervention). Adverse events, patient-reported outcomes, and passive knee stability were recorded over 2 years after the index surgery. Three-dimensional bone tunnel widening was assessed using computed tomography at the time of surgery and 4.5 months and 1 year postoperatively.

RESULTS

The intervention group exhibited a similar number of adverse events as the control group (8 vs 10; = .775) including 2 partial reruptures in both groups. The approach was feasible, although 1 case was encountered where the osteoconductive scaffold was malpositioned without adversely affecting the patient's recovery. There was no difference between the intervention and control groups in femoral bone tunnel enlargement, as expressed by the relative change in tunnel volume from surgery to 4.5 months (mean ± SD, 36% ± 25% vs 40% ± 25%; = .644) and 1 year (19% ± 20% vs 17% ± 25%; =.698).

CONCLUSION

Press-fit graft fixation with an osteoconductive scaffold positioned at the femoral tunnel aperture is safe but does not decrease femoral bone tunnel enlargement at postoperative 1 year.

REGISTRATION

NCT03462823 (ClinicalTrials.gov identifier).

摘要

背景

单束前交叉韧带重建术后骨隧道扩大仍是一个未解决的问题,这使翻修手术变得复杂。

假设

在股骨隧道开口处放置骨传导支架可改善移植物与骨的融合,从而减少骨隧道增宽。

研究设计

随机对照试验;证据等级,1级。

方法

56例行初次前交叉韧带重建的患者按1:1比例随机分为两组,一组仅在肌腱移植物隧道开口处采用皮质悬吊固定和二次压配固定进行股骨固定(对照组),另一组采用骨传导支架增强固定(干预组)。在初次手术后2年内记录不良事件、患者报告的结局和被动膝关节稳定性。在手术时、术后4.5个月和1年使用计算机断层扫描评估三维骨隧道增宽情况。

结果

干预组不良事件数量与对照组相似(8例对10例;P = 0.775),两组均有2例部分再断裂。该方法可行,尽管有1例骨传导支架位置不当,但未对患者恢复产生不利影响。干预组和对照组在股骨骨隧道扩大方面无差异,从手术到4.5个月时隧道体积的相对变化(均值±标准差,36%±25%对40%±25%;P = 0.644)以及到1年时(19%±20%对17%±25%;P = 0.698)均如此。

结论

在股骨隧道开口处放置骨传导支架进行压配移植物固定是安全的,但在术后1年并不能减少股骨骨隧道扩大。

注册信息

NCT03462823(ClinicalTrials.gov标识符)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/18f1f43c25b2/10.1177_23259671231174478-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/012395085bf1/10.1177_23259671231174478-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/6a0753aacaac/10.1177_23259671231174478-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/1d48cca7ce9f/10.1177_23259671231174478-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/ee2b3191a406/10.1177_23259671231174478-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/18f1f43c25b2/10.1177_23259671231174478-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/012395085bf1/10.1177_23259671231174478-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/6a0753aacaac/10.1177_23259671231174478-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/1d48cca7ce9f/10.1177_23259671231174478-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/ee2b3191a406/10.1177_23259671231174478-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d942/10280525/18f1f43c25b2/10.1177_23259671231174478-fig5.jpg

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Comparative Risk-Benefit Profiles of Individual Devices for Graft Fixation in Anterior Cruciate Ligament Reconstruction: A Systematic Review and Network Meta-analysis.在 ACL 重建中用于移植物固定的单个器械的比较风险效益特征:系统评价和网络荟萃分析。
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Influence of Graft Bending Angle on Graft Maturation, the Femoral Tunnel, and Functional Outcomes by 12 Months After Anterior Cruciate Ligament Reconstruction.
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