Evangelopoulos Dimitrios S, Kohl Sandro, Schwienbacher Stefan, Gantenbein Benjamin, Exadaktylos Aristomenis, Ahmad Sufian S
Department of Orthopaedic Surgery and Traumatology, Inselspital, University of Bern, Bern, Switzerland.
Institute for Surgical Technology and Biomechanics (ISTB), University of Bern, Bern, Switzerland.
Knee Surg Sports Traumatol Arthrosc. 2017 Aug;25(8):2414-2419. doi: 10.1007/s00167-015-3838-7. Epub 2015 Nov 12.
Dynamic intraligamentary stabilization was recently proposed as an option for the treatment of acute ACL ruptures. The aim of this study was to investigate the feasibility of the procedure in mid-substance ACL ruptures and examine whether the additional application of a bilayer collagen I/III membrane would provide for a superior outcome.
The study group consisted of patients presenting with a mid-substance ACL rupture undergoing dynamic intraligamentary stabilization using the Ligamys™ device along with application of a collagen I/III membrane to the surface of the ACL (group A, n = 23). The control group comprised a matched series of patients presenting with a mid-substance ACL rupture also treated by dynamic intraligamentary stabilization Ligamys™ repair, however, without additional collagen application (group B, n = 33). Patients were evaluated preoperatively and at 24-month follow-up for stability as well as Tegner and Lysholm scores. Knee laxity was measured as a difference in anterior translation (ΔAP) and pivot shift. Any events occurring during the follow-up period of 24 months were documented. Logistic regression of complications was performed, and adjustment undertaken where necessary.
A high total complication rate of 78.8 % was noted in group B, compared to group A (8.7 %) (p = 0.002). The addition of a collagen membrane was the only independent prognostic factor associated with reduced complications (OR 8.0, CI 2.0-32.2, p = 0.003, for collagen-free treatment). In group B, 6 patients suffered a re-rupture with subsequent instability requiring secondary hamstring reconstruction surgery, and 11 developed extension loss requiring arthroscopic debridement, whilst in group A, 2 patients required arthroscopic debridement for loss of exension, with no further encountered complication. Median Lysholm score was significantly higher in group A compared to group B (median 100 range 93-100 vs median 95 range 60-100, p = 0.03) at final follow-up.
A high complication rate following ACL Ligamys™ repair of mid-substance ruptures was noted. Application of a collagen membrane to the surface of the ACL resulted in a reduced incidence of extension deficit and re-ruptures. The results indicate that solitary ACL Ligamys™ repair does not present an appropriate treatment modality for mid-substance ACL ruptures. Collage application proved to provide healing benefits with superior clinical outcome after ACL repair.
Case control study, Level III.
动态韧带内稳定术最近被提议作为治疗急性前交叉韧带（ACL）断裂的一种选择。本研究的目的是探讨该手术在ACL中部断裂中的可行性，并检查双层I/III型胶原膜的额外应用是否能带来更好的结果。
研究组由患有ACL中部断裂的患者组成，他们使用Ligamys™装置进行动态韧带内稳定术，并在ACL表面应用I/III型胶原膜（A组，n = 23）。对照组由一系列匹配的患有ACL中部断裂的患者组成，他们也接受了Ligamys™动态韧带内稳定修复术，但未额外应用胶原（B组，n = 33）。对患者进行术前评估以及24个月随访，评估稳定性、Tegner评分和Lysholm评分。通过测量前向平移差异（ΔAP）和轴移来评估膝关节松弛度。记录24个月随访期间发生的任何事件。对并发症进行逻辑回归分析，并在必要时进行调整。
B组的总并发症发生率高达78.8%，而A组为8.7%（p = 0.002）。添加胶原膜是与并发症减少相关的唯一独立预后因素（无胶原治疗的OR为8.0，CI为2.0 - 32.2，p = 0.003）。在B组中，6例患者发生再次断裂并随后出现不稳定，需要进行二次腘绳肌重建手术，11例出现伸展受限，需要关节镜下清创；而在A组中，2例患者因伸展受限需要关节镜下清创，未再出现其他并发症。在最终随访时，A组的Lysholm评分中位数显著高于B组（中位数100，范围93 - 100 vs中位数95，范围60 - 100，p = 0.03）。
注意到在ACL中部断裂的Ligamys™修复术后并发症发生率较高。在ACL表面应用胶原膜可降低伸展受限和再次断裂的发生率。结果表明，单纯的ACL Ligamys™修复术并非ACL中部断裂的合适治疗方式。应用胶原被证明能在ACL修复后提供愈合益处并带来更好的临床结果。
病例对照研究，III级。
