Farid Ajmal, Gommers Sophie A, Sierevelt Inger N, van Eijk Floor, van Kampen Paulien M, Haverkamp Daniël
Department of Orthopaedic Surgery, Xpert Clinics Orthopedie, Amsterdam, The Netherlands.
Department of Orthopaedic Surgery, Bergman Clinics, Rijswijk, The Netherlands.
J Exp Orthop. 2023 May 5;10(1):52. doi: 10.1186/s40634-023-00614-y.
The aim of this study was to assess graft failure, revision rate, and functional outcomes after treatment of acute ACL rupture with dynamic intraligamentary stabilization (DIS) Ligamys device one year post surgery. Additionally, differences in functional outcome between patients with and without anteroposterior laxity were assessed. It was hypothesized that the failure rate of DIS was non-inferior to that of previously reported ACL reconstruction (10%).
In this prospectively designed multicenter study, including patients with an acute ACL rupture, DIS was performed within 21 days after rupture. Primary outcome was failure of the graft at 1 year post surgery, defined as 1) re-rupture of the graft, 2) revision of DIS, or 3) a > 3 mm side-to-side difference in anterior tibial translation compared to the non-operated knee (∆ATT), measured by the KT1000 device. Additional analysis was performed using a 5 mm threshold. The subjective International Knee Documentation Committee Score (IKDC) and Numerical Rating Scales (NRS) for pain and confidence were used to evaluate functional outcome.
A total of 155 patients were included with a mean age at surgery of 27.8 years (SD 9.4). The mean interval from rupture to DIS was 16.4 days (SD 5.2). At a median follow-up of 13 months (IQR 12-18) the failure rate of the graft was 30.2% (95%CI:22.0-39.4); 11 patients (7%) required secondary reconstructive surgery and of the 105 patients who attended ATT measurement, 24 patients (23%) had an ∆ATT > 3 mm. Secondary analysis, based on a 5 mm threshold, revealed a failure rate of 22.4% (95%CI: 15.2; 31.1). A total of 39 patients (25%) reported at least one complication, comprising mainly arthrofibrosis, traumatic re-rupture and pain. In these patients, removal of the monoblock was performed in 21 cases (13.5%). At follow-up no significant differences in functional outcomes between patients with ∆ATT > 3 mm and stable ATT were observed.
This prospective multicenter study found a high failure rate at one year follow-up of 30% (7% revision surgery and 23% > 3 mm side-to-side difference in anterior tibial translation) in patients treated by primary repair of the ACL with DIS, and did therefore not demonstrate non-inferiority to ACL reconstruction. For patients who did not require secondary reconstructive surgery, this study found good functional outcomes, also in case of persistent anteroposterior knee laxity (∆ATT > 3 mm).
Level IV.
本研究旨在评估急性前交叉韧带（ACL）断裂患者采用动态韧带内稳定（DIS）Ligamys装置治疗术后一年的移植物失败率、翻修率及功能结果。此外，还评估了存在和不存在前后向松弛的患者在功能结果上的差异。研究假设DIS的失败率不劣于先前报道的ACL重建的失败率（10%）。
在这项前瞻性设计的多中心研究中，纳入急性ACL断裂患者，在断裂后21天内进行DIS治疗。主要结局是术后1年移植物失败，定义为：1）移植物再次断裂；2）DIS翻修；3）与未手术侧膝关节相比，前向胫骨平移的侧方差异大于3mm（∆ATT），采用KT1000装置测量。还使用5mm阈值进行了额外分析。使用主观国际膝关节文献委员会评分（IKDC）以及疼痛和信心的数字评分量表（NRS）来评估功能结果。
共纳入155例患者，手术时的平均年龄为27.8岁（标准差9.4）。从断裂到DIS的平均间隔时间为16.4天（标准差5.2）。在中位随访13个月（四分位间距12 - 18个月）时，移植物失败率为30.2%（95%置信区间：22.0 - 39.4）；11例患者（7%）需要二次重建手术，在105例接受∆ATT测量的患者中，24例患者（23%）的∆ATT大于3mm。基于5mm阈值的二次分析显示失败率为22.4%（95%置信区间：15.2；31.1）。共有39例患者（25%）报告至少一种并发症，主要包括关节纤维化、创伤性再次断裂和疼痛。在这些患者中，21例（13.5%）进行了整块移除。随访时，未观察到∆ATT大于3mm的患者与∆ATT稳定的患者在功能结果上有显著差异。
这项前瞻性多中心研究发现，采用DIS对ACL进行初次修复治疗的患者在一年随访时失败率较高，为30%（7%进行翻修手术，23%前向胫骨平移的侧方差异大于3mm），因此未显示出不劣于ACL重建。对于不需要二次重建手术的患者，本研究发现其功能结果良好，即使存在持续性膝关节前后向松弛（∆ATT大于3mm）。
四级。
