Letsch R
Universitätsklinikum Essen, Medizinische Einrichtungen der Universität-GHS-Essen, Abteilung für Unfallchirurgie, Germany.
Knee Surg Sports Traumatol Arthrosc. 1994;2(2):107-17. doi: 10.1007/BF01476483.
Under certain well-defined indications alloplastic material may be used in cruciate ligament surgery. The stability and survival of such a synthetic ligament is to a great extent dependent on the anchorage with which it is fastened to the bone. Most fixation methods have proved to be too weak or have revealed other essential drawbacks, resulting in clinical and experimental failure. A new ligament fixation device (LFD) was developed and tested biomechanically and in animal experiments. In the biomechanic investigation the new LFD was compared to single staples, double staples in the belt-buckle technique, and ligament guidance through additional bone tunnels (Z-technique). The tests were carried out on human cadaver knees, plastic bones, and dog stifle joints. The evaluated parameters were linear and maximum load, stiffness, and elongation. In addition, hysteresis tests were performed to assay the long-term resistance of the fixation. The tests showed a significant superiority of the LFD in all measured variables compared to the other anchorages. The pull-out strength, at 1866 +/- 43 N (cadaver knee), was about four times that for the single staple, and about twice as high as that for the double staple and Z-technique. The animal experiments were performed on German shepherd cross-breed dogs. In six animals the anterior cruciate ligaments were excised bilaterally and replaced by a 6-mm Trevira ligament, on one side anchored with staples in the Z-technique, on the other with the LFD. Postoperatively the dogs were allowed to move freely; no additional protection was employed. After 6 months the animals were sacrificed and the knees examined macroscopically, radiologically, microscopically, and by biomechanical testing. After half a year of implantation, the pull-out strength of the alloplastic ligament was 662 +/- 62 N for the LFD and 531 +/- 67 N for the staples. Three ligaments in the staple group and one in the LFD group had ruptured completely, and two ligaments partially, one in each group. The average anterior drawer in the LFD group was 2.8 mm, in the staple group 4.0 mm. In all cases the alloplastic ligament was separated from the bone by a fibrous interface. None of the fixation devices showed signs of loosening. There was no foreign body reaction around the anchorages. Major cartilage degeneration was observed in two stifle joints of each group, mainly associated with instability.
在某些明确界定的适应症下,同种异体材料可用于交叉韧带手术。这种合成韧带的稳定性和存活率在很大程度上取决于其与骨骼固定的锚固方式。事实证明,大多数固定方法都过于薄弱,或者存在其他严重缺陷,导致临床和实验失败。一种新型韧带固定装置(LFD)被研发出来,并进行了生物力学测试和动物实验。在生物力学研究中,将新型LFD与单钉、带扣技术中的双钉以及通过额外骨隧道的韧带引导(Z技术)进行了比较。测试在人体尸体膝关节、塑料骨和犬膝关节上进行。评估的参数包括线性和最大载荷、刚度以及伸长率。此外,还进行了滞后测试以测定固定的长期抗性。测试表明,与其他锚固方式相比,LFD在所有测量变量方面具有显著优势。在尸体膝关节上,LFD的拔出强度为1866±43 N,约为单钉的四倍,是双钉和Z技术的两倍左右。动物实验在德国牧羊犬杂交犬身上进行。在六只动物中,双侧切除前交叉韧带,并用6毫米的特韦拉韧带替代,一侧采用Z技术用钉子锚固,另一侧采用LFD锚固。术后让犬自由活动;未采取额外保护措施。6个月后处死动物,对膝关节进行宏观、放射学、显微镜检查以及生物力学测试。植入半年后,LFD组同种异体韧带的拔出强度为662±62 N,钉子组为531±67 N。钉子组有三条韧带完全断裂,LFD组有一条;两组各有一条韧带部分断裂。LFD组的平均前抽屉试验为2.8毫米,钉子组为4.0毫米。在所有情况下,同种异体韧带通过纤维界面与骨骼分离。没有任何固定装置显示出松动迹象。锚固周围没有异物反应。每组各有两个膝关节观察到严重的软骨退变,主要与不稳定有关。