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在人体尸体模型中对生物复合材料侧排无结锚进行循环生物力学测试。

Cyclic biomechanical testing of biocomposite lateral row knotless anchors in a human cadaveric model.

机构信息

Plano Orthopedic Sports Medicine and Spine Center, Plano, TX 75093, USA.

出版信息

Arthroscopy. 2013 Jun;29(6):1012-8. doi: 10.1016/j.arthro.2013.02.006. Epub 2013 Apr 9.

Abstract

PURPOSE

The purpose of this study was to assess the mechanical performance of biocomposite knotless lateral row anchors based on both anchor design and the direction of pull.

METHODS

Two lateral row greater tuberosity insertion sites (anterior and posterior) were identified in matched pairs of fresh-frozen human cadaveric shoulders DEXA (dual energy X-ray absorptiometry) scanned to verify comparability. The humeri were stripped of all soft tissue and 3 different biocomposite knotless lateral row anchors: HEALIX Knotless BR (DePuy Mitek, Raynham MA), BioComposite PushLock (Arthrex, Naples, FL), and Bio-SwiveLock (Arthrex). Fifty-two anchors were distributed among the insertion locations and tested them with either an anatomic or axial pull. A fixed-gauge loop (15 mm) of 2 high-strength sutures from each anchor was created. After a 10-Nm preload, anchors were cycled from 10 to 45 Nm at 0.5 Hz for 200 cycles and tested to failure at 4.23 mm/second. The load to reach 3 mm and 5 mm displacement, ultimate failure load, displacement at ultimate failure, and failure mode were recorded.

RESULTS

Threaded anchors (Bio-SwiveLock, P = .03; HEALIX Knotless, P = .014) showed less displacement with anatomic testing than did the nonthreaded anchor (BioComposite PushLock), and the HEALIX Knotless showed less overall displacement than did the other 2 anchors. The Bio-SwiveLock exhibited greater failure loads than did the other 2 anchors (P < .05). Comparison of axial and anatomic loading showed no maximum load differences for all anchors as a whole (P = .1084). Yet, anatomic pulling produced higher failure loads than did axial pulling for the Bio-SwiveLock but not for the BioComposite PushLock or the HEALIX Knotless. The nonthreaded anchor (BioComposite PushLock) displayed lower failure loads than did both threaded anchors with axial pulling.

CONCLUSIONS

Threaded biocomposite anchors (HEALIX Knotless BR and Bio-SwiveLock) show less anatomic loading displacement and higher axial failure loads than do the nonthreaded (BioComposite PushLock) anchor. The HEALIX Knotless BR anchor showed less displacement than did the BioComposite PushLock and Bio-SwiveLock anchors. Neither axial nor anatomic loading had an effect on overall anchor displacement.

CLINICAL RELEVANCE

Because of the strength profiles exhibited, this study supports the use of biocomposite anchors, which have definite advantages over polyetheretherketone (PEEK) and metal products. However, the nonthreaded BioComposite PushLock anchor cannot be recommended.

摘要

目的

本研究旨在评估基于锚定设计和拉力方向的生物复合材料无结侧排锚的机械性能。

方法

在经过 DEXA(双能 X 射线吸收法)扫描以验证可比性的匹配的新鲜冷冻人体尸体肩中,确定了两个侧排更大结节插入部位(前和后)。将肱骨剥离所有软组织,并使用 3 种不同的生物复合材料无结侧排锚:HEALIX Knotless BR(DePuy Mitek,雷纳姆 MA)、BioComposite PushLock(Arthrex,那不勒斯,FL)和 Bio-SwiveLock(Arthrex)。将 52 个锚分布在插入位置,并对其进行解剖或轴向拉力测试。从每个锚的 2 根高强度缝线中创建一个固定直径为 15 毫米的环。在 10-Nm 的预载下,以 0.5 Hz 的频率从 10 到 45 Nm 循环 200 次,并以 4.23 毫米/秒的速度进行至失效测试。记录达到 3 毫米和 5 毫米位移的负载、最终失效负载、最终失效时的位移和失效模式。

结果

与无螺纹锚(BioComposite PushLock)相比,带螺纹的锚(Bio-SwiveLock,P =.03;HEALIX Knotless,P =.014)在解剖测试中显示出较小的位移,而 HEALIX Knotless 显示出比其他 2 个锚更小的总位移。Bio-SwiveLock 表现出比其他 2 个锚更高的失效负载(P <.05)。轴向和解剖加载的比较表明,所有锚的最大负载没有差异(P =.1084)。然而,与轴向拉力相比,解剖拉力产生的 Bio-SwiveLock 失效负载更高,但对于 BioComposite PushLock 或 HEALIX Knotless 则不然。与带螺纹的锚(HEALIX Knotless BR 和 Bio-SwiveLock)相比,无螺纹锚(BioComposite PushLock)在轴向拉力下显示出较低的失效负载。

结论

带螺纹的生物复合材料锚(HEALIX Knotless BR 和 Bio-SwiveLock)显示出比无螺纹(BioComposite PushLock)锚更低的解剖学加载位移和更高的轴向失效负载。HEALIX Knotless BR 锚的位移小于 BioComposite PushLock 和 Bio-SwiveLock 锚。轴向和解剖加载都不会对锚的总位移产生影响。

临床相关性

由于表现出的强度特性,本研究支持使用生物复合材料锚,其相对于聚醚醚酮(PEEK)和金属产品具有明显的优势。然而,不能推荐使用无螺纹的 BioComposite PushLock 锚。

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