D. E. Axelrod, S. Ekhtiari, A. Bozzo, M. Bhandari, H. Johal, Division of Orthopaedic Surgery, McMaster University, Hamilton, ON, Canada.
M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Clin Orthop Relat Res. 2020 Feb;478(2):392-402. doi: 10.1097/CORR.0000000000000986.
Displaced mid-third clavicle fractures are common, and their management remains unclear. Although several meta-analyses have compared specific operative techniques with nonoperative management, it is not possible to compare different operative constructs with one another using a standard meta-analysis. Conversely, a network meta-analysis allows comparisons among more than two treatment arms, using both direct and indirect comparisons between interventions across many trials. To our knowledge, no network meta-analysis has been performed to compare the multiple treatment options for displaced clavicle fractures.
QUESTIONS/PURPOSES: We performed a network meta-analysis of randomized, controlled trials (RCTs) to determine from among the approaches used to treat displaced midshaft clavicle fractures: (1) the intervention with the highest chance of union at 1 year, (2) the intervention with the lowest risk of revision surgery, and (3) the intervention with the highest functional outcome scores. Secondarily, we also (4) compared the surgical subtypes in the available RCTs on the same above endpoints.
MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were reviewed for relevant randomized controlled trials published up to July 25, 2018. Two hundred and eighty four papers were reviewed, with 22 meeting inclusion criteria of RCTs with appropriate randomization techniques, adult population, minimum of 1 year follow-up and including at least one operative treatment arm. In total, 1002 patients were treated with a plate construct, 378 with an intramedullary device, and 585 patients were managed nonoperatively. Treatment subtypes included locked intramedullary devices (56), unlocked intramedullary devices (322), anterior plating (89), anterosuperior plating (150), superior plating (449) or plating not otherwise specified (314). We performed a network meta-analysis to compare and rank the treatments for displaced clavicle fractures. We considered the following outcomes: union achievement, revision surgery risk and functional outcomes (DASH and Constant Scores). The minimal clinically important difference (MCID) was considered for both Constant and DASH scores to be at 8 points, representing the average of MCID scores reported for both DASH and Constant in the evidence, respectively.
Union achievement was lower in patients treated nonoperatively (88.9%), and higher in patients treated operatively (96.7%, relative risk [RR] 1.128 [95% CI 1.1 to 1.17]; p < 0.001), Number needed to treat (NNT) = 10). Union achievement increased with any plate construct (97.8%, RR 1.13 [95% CI 1.1 to 1.7]; p < 0.0001, NNT = 9) and with anterior or anterosuperior plates (99.3%, RR 1.14 [95% CI 1.1 to 1.8]; p < 0.0001, NNT = 8). Risk of reoperation, when considering planned removal of hardware, was similar across all treatment arms. Lastly, operative treatment outperformed nonoperative treatment with minor improvements in DASH and Constant scores, though not approaching the MCID. At the subtype level, anterosuperior plating ranked highest in DASH and Constant functional scores with mean differences reaching 10-point improvement for Constant scores (95% CI 4.4 to 2.5) and 7.6 point improvement for DASH (95% CI 5.2 to 20).
We found that surgical treatment led to a greater likelihood of union at 1 year of follow-up among adult patients with displaced mid-third clavicle fractures. In aggregate, surgical treatment did not increase functional scores by amounts that patients were likely to consider clinically important. Use of specific subtypes of plating (anterior, anterosuperior) resulted in improvements in the Constant score that were slightly above the MCID but did not reach the MCID for the DASH score, suggesting that any outcomes-score benefits favoring surgery were likely to be imperceptible or small. In light of these findings, we believe patients can be informed that surgery for this injury can increase the likelihood of union incrementally (about 10 patients would need to undergo surgery to avoid one nonunion), but they should not expect better function than they would achieve without surgery; most patients can avoid surgery altogether with little absolute risk of nonunion. Patients who opt for surgery must be told that the decision should be weighed against complications and the possibility of undergoing a second procedure for hardware removal. Patients opting not to have surgery for acute midshaft clavicle fractures can be told that nonunion occurs in slightly more than 10% of patients, and that these can be more difficult to manage than acute fractures.
Level I, therapeutic study.
移位的锁骨中段骨折较为常见，但其治疗方法仍不明确。虽然有几项荟萃分析比较了特定的手术技术与非手术治疗，但使用标准荟萃分析不可能将不同的手术方法相互比较。相反，网络荟萃分析可以在多项试验中使用干预措施之间的直接和间接比较，对超过两种治疗方案进行比较。据我们所知，尚未进行网络荟萃分析比较治疗移位锁骨骨折的多种治疗选择。
问题/目的：我们对随机对照试验（RCT）进行了网络荟萃分析，以确定在治疗移位锁骨中段骨折的方法中：（1） 1 年内愈合几率最高的干预措施；（2） 翻修手术风险最低的干预措施；（3） 功能评分最高的干预措施。其次，我们还比较了 RCT 中可用的手术亚型在相同的上述终点上的情况。
我们检索了 MEDLINE、Embase 和 Cochrane 对照试验中心注册库，以获取截至 2018 年 7 月 25 日发表的相关 RCT。共审查了 284 篇论文，其中 22 篇符合 RCT 的纳入标准，包括适当的随机分组技术、成人人群、至少 1 年的随访时间以及至少有 1 个手术治疗组。共有 1002 例患者接受了钢板固定，378 例患者接受了髓内装置固定，585 例患者接受了非手术治疗。治疗亚型包括锁定髓内装置（56 例）、非锁定髓内装置（322 例）、前侧钢板固定（89 例）、前上侧钢板固定（150 例）、上侧钢板固定（449 例）或未特指的钢板固定（314 例）。我们进行了网络荟萃分析，以比较和排名治疗移位锁骨骨折的方法。我们考虑了以下结局：愈合率、翻修手术风险和功能结局（DASH 和 Constant 评分）。我们认为 DASH 和 Constant 评分的最小临床重要差异（MCID）分别为 8 分，分别代表这两个评分在证据中的 MCID 评分的平均值。
非手术治疗的患者（88.9%）愈合率较低，而手术治疗的患者（96.7%，相对风险 [RR] 1.128 [95% CI 1.1 至 1.17]；p < 0.001）、需要治疗的人数（NNT）= 10）更高。任何钢板固定（97.8%，RR 1.13 [95% CI 1.1 至 1.7]；p < 0.0001，NNT = 9）和前侧或前上侧钢板固定（99.3%，RR 1.14 [95% CI 1.1 至 1.8]；p < 0.0001，NNT = 8）的愈合率更高。考虑到计划去除内固定物，所有治疗组的翻修手术风险相似。最后，手术治疗在 DASH 和 Constant 评分方面优于非手术治疗，虽然没有达到 MCID，但有轻微改善。在亚型水平上，前上侧钢板固定在 DASH 和 Constant 功能评分中排名最高，Constant 评分的平均差异达到 10 分的改善（95% CI 4.4 至 2.5），DASH 评分的平均差异达到 7.6 分的改善（95% CI 5.2 至 20）。
我们发现，在成人移位锁骨中段骨折患者中，手术治疗在 1 年随访时更有可能实现愈合。总的来说，手术治疗并没有使功能评分提高到患者可能认为有临床意义的程度。使用特定的钢板固定亚型（前侧、前上侧）可使 Constant 评分提高约 10 分（95% CI 4.4 至 2.5），DASH 评分提高 7.6 分（95% CI 5.2 至 20），略高于 MCID，但未达到 DASH 评分的 MCID，这表明任何有利于手术的结果评分获益可能是难以察觉或微不足道的。鉴于这些发现，我们认为患者可以被告知手术治疗可能会略微增加愈合的可能性（大约需要 10 例患者接受手术才能避免 1 例不愈合），但他们不应期望手术能带来比不手术更好的功能；大多数患者可以完全避免手术，绝对不愈合的风险很小。选择手术的患者必须被告知，应权衡利弊，权衡并发症和去除内固定物的可能性。选择不接受急性锁骨中段骨折手术的患者可以告知他们，10%以上的患者会出现不愈合，而且这些患者比急性骨折更难处理。
一级，治疗性研究。
