Division of Orthopaedic Surgery, University of Ottawa, Ottawa, ON, Canada.
Centre for Practice-Changing Research, The Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Clin Orthop Relat Res. 2021 Oct 1;479(10):2119-2131. doi: 10.1097/CORR.0000000000001861.
Uncertainty exists regarding the best treatment for acute Achilles tendon ruptures. Simultaneous comparison of the multiple treatment options using traditional study designs is problematic; multiarm clinical trials often are logistically constrained to small sample sizes, and traditional meta-analyses are limited to comparisons of only two treatments that have been compared in head-to-head trials. Network meta-analyses allow for simultaneous comparison of all existing treatments utilizing both direct (head-to-head comparison) and indirect (not previously compared head-to-head) evidence.
QUESTIONS/PURPOSES: We performed a network meta-analysis of randomized controlled trials (RCTs) to answer the following questions: Considering open repair, minimally invasive surgery (MIS) repair, functional rehabilitation, or primary immobilization for acute Achilles tendon ruptures, (1) which intervention is associated with the lowest risk of rerupture? (2) Which intervention is associated with the lowest risk of complications resulting in surgery?
This study was conducted with methods guided by the Cochrane Handbook for Systematic Reviews of Interventions and is reported in adherence with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension statement for incorporating network meta-analysis. Five databases and grey literature sources (such as major orthopaedic meeting presentation lists) were searched from inception to September 30, 2019. Included studies were RCTs comparing treatment of acute Achilles tendon ruptures using two or more of the following interventions: primary immobilization, functional rehabilitation, open surgical repair, or MIS repair. We excluded studies enrolling patients with chronic ruptures, reruptures, and preexisting Achilles tendinopathy as well as studies with more than 20% loss to follow-up or less than 6 months of follow-up. Nineteen RCTs (1316 patients) were included in the final analysis. The mean number of patients per study treatment arm was 35 ± 16, mean age was 41 ± 5 years, mean sex composition was 80% ± 10% males, and mean follow-up was 22 ± 12 months. The four treatment groups were compared for the main outcomes of rerupture and complications resulting in operation. The analysis was conducted using random-effects Bayesian network meta-analysis with vague priors. Evidence quality was evaluated using Grades of Recommendation, Assessment, Development, and Evaluation methodology. We found risk of selection, attrition, and reporting bias to be low across treatments, and we found the risk of performance and detection bias to be high. Overall risk of bias between treatments appeared similar.
We found that treatment with primary immobilization had a greater risk of rerupture than open surgery (odds ratio 4.06 [95% credible interval {CrI} 1.47 to 11.88]; p < 0.05). There were no other differences between treatments for risk of rerupture. Minimally invasive surgery was ranked first for fewest complications resulting in surgery and was associated with a lower risk of complications resulting in surgery than functional rehabilitation (OR 0.16 [95% CrI 0.02 to 0.90]; p < 0.05), open surgery (OR 0.22 [95% CrI 0.04 to 0.93]; p < 0.05), and primary immobilization (OR < 0.01 [95% CrI < 0.01 to 0.01]; p < 0.05). Risk of complications resulting in surgery was no different between primary immobilization and open surgery (OR 1.46 [95% CrI 0.35 to 5.36]). Data for patient-reported outcome scores and return to activity were inappropriate for pooling secondary to considerable clinical heterogeneity and imprecision associated with small sample sizes.
Faced with acute Achilles tendon rupture, patients should be counseled that, based on the best-available evidence, the risk of rerupture likely is no different across contemporary treatments. Considering the possibly lower risk of complications resulting in surgery associated with MIS repair, patients and surgeons must balance any benefit with the potential risks of MIS techniques. As treatments continue to evolve, consistent reporting of validated patient-reported outcome measures is critically important to facilitate analysis with existing RCT evidence. Infrequent but serious complications such as rerupture and deep infection should be further explored to determine whether meaningful differences exist in specific patient populations.
Level I, therapeutic study.
对于急性跟腱断裂的最佳治疗方法存在不确定性。使用传统研究设计同时比较多种治疗方案存在问题；多臂临床试验通常受到小样本量的限制，而传统的荟萃分析仅限于已在头对头试验中进行比较的两种治疗方法的比较。网络荟萃分析允许利用直接（头对头比较）和间接（以前未对头对头比较）证据同时比较所有现有的治疗方法。
问题/目的：我们对随机对照试验（RCT）进行了网络荟萃分析，以回答以下问题：考虑开放性修复、微创外科（MIS）修复、功能康复或急性跟腱断裂的原发性固定，（1）哪种干预措施与再断裂的风险最低相关？（2）哪种干预措施与导致手术的并发症的风险最低相关？
本研究采用循证医学干预措施系统评价指南指导的方法进行，并按照纳入网络荟萃分析的系统评价和荟萃分析扩展声明的报告原则进行报告。从成立到 2019 年 9 月 30 日，我们在五个数据库和灰色文献来源（如主要骨科会议演讲列表）中进行了搜索。纳入的研究是比较急性跟腱断裂治疗的 RCT，使用两种或多种以下干预措施：原发性固定、功能康复、开放性手术修复或 MIS 修复。我们排除了招募慢性断裂、再断裂和预先存在的跟腱病患者的研究，以及随访丢失超过 20%或随访时间少于 6 个月的研究。19 项 RCT（1316 名患者）被纳入最终分析。每个研究治疗组的平均患者人数为 35±16，平均年龄为 41±5 岁，平均性别构成为 80%±10%男性，平均随访时间为 22±12 个月。比较了四种治疗组的主要结局，即再断裂和导致手术的并发症。分析采用随机效应贝叶斯网络荟萃分析，使用模糊先验。使用推荐、评估、制定和评估方法学评估证据质量。我们发现，在所有治疗方法中，原发性固定的再断裂风险高于开放性手术（比值比 4.06[95%可信区间{CrI}1.47 至 11.88]；p<0.05）。治疗之间没有其他再断裂风险的差异。MIS 被认为是导致手术并发症最少的治疗方法，与功能康复（OR 0.16[95%CrI 0.02 至 0.90]；p<0.05）、开放性手术（OR 0.22[95%CrI 0.04 至 0.93]；p<0.05）和原发性固定（OR<0.01[95%CrI<0.01 至 0.01]；p<0.05）相比，发生手术并发症的风险较低。原发性固定与开放性手术之间（OR 1.46[95%CrI 0.35 至 5.36]）手术并发症的风险没有差异。由于小样本量相关的临床异质性和不精确性，患者报告的结果评分和恢复活动的数据不适合汇总进行二次分析。
面对急性跟腱断裂，患者应该被告知，根据最佳现有证据，当代治疗方法的再断裂风险可能没有差异。考虑到 MIS 修复与手术相关并发症风险较低的可能益处，患者和外科医生必须权衡任何益处与 MIS 技术的潜在风险。随着治疗方法的不断发展，及时报告经过验证的患者报告结果测量指标对于利用现有 RCT 证据进行分析至关重要。应进一步探讨罕见但严重的并发症，如再断裂和深部感染，以确定在特定患者群体中是否存在有意义的差异。
I 级，治疗性研究。
