Clinique du Sport Paris, 36 Boulevard Saint Marcel, 75005, Paris, France.
Racing 92, 11 Avenue du Plessis, 92350, Plessis-Robinson, France.
Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2578-2585. doi: 10.1007/s00167-020-05879-9. Epub 2020 Feb 5.
To compare return to sport and knee function 1 year after anterior cruciate ligament (ACL) reconstruction using autografts with and without vancomycin presoaking.
A case-control study based on a retrospective analysis of prospective data included athletes over the age of 16 operated from 2012 to 2018 for ACL reconstruction. There were two groups of patients due to a change in treatment protocols: Group 1 « without vancomycin » before November 2016 and Group 2 « with vancomycin» after this date. In Group 2, the graft was soaked in a vancomycin solution for 10 min and then fixed into the bone tunnels. The primary evaluation criterion was the return to sport 1 year after surgery. The secondary criteria were various knee scores. The number of patients needed to perform a non-inferiority study was calculated.
1674 patients fulfilled the selection criteria, 1184 in Group 1 and 490 in Group 2. The series included 1112 men and 562 women, mean age 30 ± 9.7 years, 68 professional athletes, 674 competitive athletes and 932 recreational athletes. While seven patients presented with post-operative septic arthritis in Group 1, this complication was not found in Group 2. No significant difference was identified in the return to running between the two groups 1 year after surgery (75.9% vs. 76.1%, n.s.). Significantly more of the patients in Group 2 returned to their preinjury sport (p = 0.04). Knee function was comparable between the groups.
Vancomycin-soaked grafts during ACL reconstruction reduce the risk of post-operative infection of the knee without affecting the return to sport or knee function.
III.
https://clinicaltrials.gov/ , ClinicalTrials.gov Identifier: NCT02511158.
比较使用和不使用万古霉素浸泡的自体移植物进行前交叉韧带(ACL)重建 1 年后的运动回归和膝关节功能。
本病例对照研究基于对前瞻性数据的回顾性分析,纳入了 2012 年至 2018 年间接受 ACL 重建手术的 16 岁以上运动员。由于治疗方案的改变,患者分为两组:2016 年 11 月前为第 1 组(无万古霉素),此后为第 2 组(有万古霉素)。在第 2 组中,移植物在万古霉素溶液中浸泡 10 分钟,然后固定在骨隧道中。主要评估标准是术后 1 年的运动回归。次要标准为各种膝关节评分。计算了进行非劣效性研究所需的患者数量。
1674 名患者符合入选标准,其中第 1 组 1184 例,第 2 组 490 例。该系列包括 1112 名男性和 562 名女性,平均年龄 30±9.7 岁,68 名职业运动员,674 名竞技运动员和 932 名娱乐运动员。第 1 组中有 7 例患者术后发生化脓性关节炎,而第 2 组中未发现该并发症。手术后 1 年两组在跑步回归方面无显著差异(75.9% vs. 76.1%,n.s.)。第 2 组中有更多的患者回到受伤前的运动(p=0.04)。两组膝关节功能相当。
ACL 重建时使用万古霉素浸泡移植物可降低膝关节感染的风险,而不影响运动回归或膝关节功能。
III 级。
https://clinicaltrials.gov/ ,ClinicalTrials.gov 标识符:NCT02511158。