Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland (Bruderholz, Liestal, Laufen), 4101, Bruderholz, Switzerland.
Amsler Consulting, Basel, Switzerland.
Knee Surg Sports Traumatol Arthrosc. 2018 Feb;26(2):655-659. doi: 10.1007/s00167-017-4726-0. Epub 2017 Sep 22.
Most of the clinical outcome studies dealing with ACL repair are from the developer's perspective. It is a fact that these developer-initiated studies tend to interpret the results rather in favour than against their developed technique or product. Hence, it was the purpose of the present independent investigator-initiated study to investigate the clinical and radiological outcomes as well as failure rate of patients who underwent an ACL suture using dynamic intraligamentary stabilisation device in a specialised independent knee clinic.
A retrospective study was performed on prospectively collected data of 26 patients (28 ± 9 years, range 18-50 years; male/female = 17:9) who underwent biologically augmented ACL suture using dynamic intraligamentary stabilisation. Mean time from ACL injury was 15 ± 5 days (range 4-25 days). In addition, in seven (27%) patients a medial meniscus refixation and in four (15%) patients a lateral meniscus refixation was done for associated meniscal lesions. All patients were clinically and radiologically followed up at 6 weeks, 3 and 12 months after ACL surgery using the Tegner and Lysholm score as well as IKDC score. Adverse events such as ACL failure, arthrofibrosis, pain > 3 on a visual analogue scale as well as the need and type of revision surgery were noted.
Four patients (15%) suffered from an ACL retear due to another adequate trauma during follow-up time. In six patients (23%), an arthrofibrosis (extension deficit of > 10° or flexion deficit > 20°) was noted. In five of those six patients, an arthroscopic arthrolysis was performed. Three patients also complained about pain VAS > 3. In nine (35%) patients, superfluous ACL scar tissue and the DIS device including the polyethylene suture and the DIS screw were removed, and in another two (8%) patients, the DIS screw only was removed. In two patients, a partial meniscectomy was performed due to a non-healed meniscal suture. The median Tegner score was 8 (range 6-10) before injury and 7 (range 3-10) at last follow-up (p < 0.001). The mean Lysholm score before surgery was 28 ± 14 and 94 ± 11 at last follow-up (p < 0.001). At last follow-up, 14 patients (66%) showed a normal total IKDC score (A) and 4 patients (19%) were nearly normal (B) and 2 patients (10%) were slightly abnormal (C) and one patient (5%) was entirely abnormal (p < 0.001).
ACL suturing using the dynamic intraligamentary stabilisation device showed satisfying clinical results at 12-month follow-up. However, a retear rate of 15% and a reoperation rate of 35% due to retear or arthrofibrosis appear rather high. These results highlight the importance of adequate patient selection and the delicacy of the surgical procedure.
Retrospective case series, Level IV.
大多数涉及 ACL 修复的临床结果研究都来自于开发者的角度。事实上，这些由开发者发起的研究往往更倾向于解释有利于他们开发的技术或产品的结果，而不是反对。因此，本研究的目的是调查在一家专门的膝关节诊所中，使用动态韧带内稳定装置进行 ACL 缝合的患者的临床和放射学结果以及失败率。
对 26 名（28±9 岁，18-50 岁；男/女=17:9）接受生物增强 ACL 缝合的前瞻性收集数据进行回顾性研究，使用动态韧带内稳定装置。ACL 损伤后平均时间为 15±5 天（4-25 天）。此外，在 7 名（27%）患者中进行了内侧半月板修复固定，在 4 名（15%）患者中进行了外侧半月板修复固定。所有患者均在 ACL 手术后 6 周、3 个月和 12 个月进行临床和放射学随访，采用 Tegner 和 Lysholm 评分以及 IKDC 评分。记录 ACL 失败、关节纤维化、视觉模拟评分>3 的疼痛以及需要和类型的翻修手术等不良事件。
4 名患者（15%）在随访期间因其他适当创伤而再次出现 ACL 撕裂。在 6 名患者（23%）中，出现了关节纤维化（伸展度缺失>10°或屈曲度缺失>20°）。在这 6 名患者中的 5 名中，进行了关节镜松解术。5 名患者还主诉 VAS 疼痛>3。在 9 名患者（35%）中，去除了多余的 ACL 疤痕组织和 DIS 装置，包括聚乙烯缝线和 DIS 螺钉，在另外 2 名患者（8%）中，仅去除了 DIS 螺钉。在 2 名患者中，由于半月板缝合未愈合，进行了部分半月板切除术。损伤前的中位数 Tegner 评分为 8（6-10），末次随访时为 7（3-10）（p<0.001）。术前平均 Lysholm 评分为 28±14，末次随访时为 94±11（p<0.001）。末次随访时，14 名患者（66%）的总 IKDC 评分正常（A），4 名患者（19%）接近正常（B），2 名患者（10%）稍异常（C），1 名患者（5%）完全异常（p<0.001）。
ACL 缝合使用动态韧带内稳定装置在 12 个月的随访中显示出满意的临床结果。然而，15%的再撕裂率和 35%的因再撕裂或关节纤维化而再次手术率似乎较高。这些结果强调了适当的患者选择和手术精细度的重要性。
回顾性病例系列，IV 级。
