Capuano Luca, Hardy Philippe, Longo Umile Giuseppe, Denaro Vincenzo, Maffulli Nicola
Orthopaedic Department, Ambroise Paré Hospital, West Paris University, Boulogne, France.
Knee. 2008 Jun;15(3):174-9. doi: 10.1016/j.knee.2008.02.003. Epub 2008 Mar 25.
Hamstring tendon autograft has become a popular graft choice for anterior cruciate ligament (ACL) reconstruction, but there is no consensus on the ideal technique of fixation. We performed a pilot randomized controlled study to compare the clinical and mechanical outcome of two femoral fixation techniques for anterior cruciate ligament (ACL) reconstruction using hamstrings graft. We recruited 30 patients with a chronic unilateral tear of the anterior cruciate ligament. In all patients, quadrupled hamstring graft was used for ACL reconstruction. In 15 patients, femoral graft fixation was performed using Bio-interference Screws fixation (Arthrex, Inc. Naples USA) (Group 1). In the other 15 patients, femoral graft fixation was performed using BioTransFix femur extra cortical transverse fixation (Arthrex, Inc. Naples USA) (Group 2). In both groups, tibial fixation was achieved with a Delta bio-absorbable interference screw (Arthrex). Both groups were comparable with regard to demographic data, pre-operative activity level, mechanism of injury, interval between the injury and the operation, and pre-operative knee laxity measurements. An independent observer, who was blinded with regard to the involved leg and the type of graft, performed the outcome assessment with the use of a Rolimeter arthrometer (Aircast), and the International Knee Documentation Committee. At 13 months follow up, all patients except one had functionally normal or nearly normal IKDC objective scores. The mean IKDC subjective score was 83.38+/-9.4 in Group 1 and 79.92+/-11.01 in Group 2 (P>.05). The side to side laxity as measured with the Rolimeter arthrometer was 1.5 mm+/-1 (range 0-3) for Group 1, and 2 mm+/-1 (range 0-3) for Group 2 (P>.05). Femoral Biotransfix fixation and Bio-interference Screws fixation provide comparable mechanical stability and clinical outcome at 13 months follow up. BiotransFix fixation is an effective alternative to other devices. Our preliminary study shows that there is no evidence to prefer femoral transfixation to the more traditional, technically less demanding, and more economical interference screw fixation. A full study requires 368 participants.
腘绳肌腱自体移植已成为前交叉韧带（ACL）重建中一种常用的移植物选择，但在理想的固定技术上尚未达成共识。我们进行了一项初步随机对照研究，以比较两种使用腘绳肌移植物进行前交叉韧带（ACL）重建的股骨固定技术的临床和力学结果。我们招募了30例慢性单侧前交叉韧带撕裂患者。所有患者均使用四股腘绳肌移植物进行ACL重建。15例患者采用生物干扰螺钉固定（美国那不勒斯的Arthrex公司）进行股骨移植物固定（第1组）。另外15例患者采用BioTransFix股骨皮质外横向固定（美国那不勒斯的Arthrex公司）进行股骨移植物固定（第2组）。两组均使用Delta生物可吸收干扰螺钉（Arthrex）进行胫骨固定。两组在人口统计学数据、术前活动水平、损伤机制、损伤与手术间隔时间以及术前膝关节松弛度测量方面具有可比性。一名对患侧和移植物类型不知情的独立观察者使用Rolimeter关节测量仪（Aircast）和国际膝关节文献委员会进行结果评估。在13个月的随访中，除1例患者外，所有患者的国际膝关节文献委员会（IKDC）客观评分功能正常或接近正常。第1组的平均IKDC主观评分为83.38±9.4，第2组为79.92±11.01（P>0.05）。使用Rolimeter关节测量仪测量的两侧松弛度，第1组为1.5 mm±1（范围0 - 3），第2组为2 mm±1（范围0 - 3）（P>0.05）。在13个月的随访中，股骨BioTransFix固定和生物干扰螺钉固定提供了相当的力学稳定性和临床结果。BioTransFix固定是其他装置的有效替代方法。我们的初步研究表明，没有证据表明股骨贯穿固定比更传统、技术要求更低且更经济的干扰螺钉固定更具优势。完整的研究需要368名参与者。
