The Edinburgh Shoulder Clinic, The New Royal Infirmary of Edinburgh, Little France, Edinburgh EH16 4SU, United Kingdom.
J Bone Joint Surg Am. 2013 Sep 4;95(17):1576-84. doi: 10.2106/JBJS.L.00307.
There is a growing trend to treat displaced midshaft clavicular fractures with primary open reduction and plate fixation; whether such treatment results in improved patient outcomes is debatable. The aim of this multicenter, single-blinded, randomized controlled trial was to compare union rates, functional outcomes, and economic costs for displaced midshaft clavicular fractures that were treated with either primary open reduction and plate fixation or nonoperative treatment.
In a prospective, multicenter, stratified, randomized controlled trial, 200 patients between sixteen and sixty years of age who had an acute displaced midshaft clavicular fracture were randomized to receive either primary open reduction and plate fixation or nonoperative treatment. Functional assessment was conducted at six weeks, three months, six months, and one year with use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Constant scores. Union was evaluated with use of three-dimensional computed tomography. Complications were recorded, and an economic evaluation was performed.
The rate of nonunion was significantly reduced after open reduction and plate fixation (one nonunion) as compared with nonoperative treatment (sixteen nonunions) (relative risk = 0.07; p = 0.007). Group allocation to nonoperative treatment was independently predictive of the development of nonunion (p = 0.0001). Overall, DASH and Constant scores were significantly better after open reduction and plate fixation than after nonoperative treatment at the time of the one-year follow-up (DASH score, 3.4 versus 6.1 [p = 0.04]; Constant score, 92.0 versus 87.8 [p = 0.01]). However, when patients with nonunion were excluded from analysis, there were no significant differences in the Constant scores or DASH scores at any time point. Patients were less dissatisfied with symptoms of shoulder droop, local bump at the fracture site, and shoulder asymmetry in the open reduction and plate fixation group (p < 0.0001). The cost of treatment was significantly greater after open reduction and plate fixation (p < 0.0001).
Open reduction and plate fixation reduces the rate of nonunion after acute displaced midshaft clavicular fracture compared with nonoperative treatment and is associated with better functional outcomes. However, the improved outcomes appear to result from the prevention of nonunion by open reduction and plate fixation. Open reduction and plate fixation is more expensive and is associated with implant-related complications that are not seen in association with nonoperative treatment. The results of the present study do not support routine primary open reduction and plate fixation for the treatment of displaced midshaft clavicular fractures.
目前，越来越多的医生倾向于对移位的锁骨中段骨折进行切开复位内固定治疗；但这种治疗方式是否能改善患者预后，仍存在争议。本多中心、单盲、随机对照试验旨在比较切开复位内固定与非手术治疗移位锁骨中段骨折的愈合率、功能结果和经济成本。
采用前瞻性、多中心、分层、随机对照试验，纳入年龄在 16 岁至 60 岁之间的 200 例急性移位锁骨中段骨折患者，随机分为切开复位内固定组或非手术治疗组。分别在 6 周、3 个月、6 个月和 1 年时采用 DASH 评分和 Constant 评分进行功能评估。采用三维 CT 评估愈合情况。记录并发症，并进行经济评估。
切开复位内固定组的骨不愈合率（1 例）显著低于非手术治疗组（16 例）（相对风险=0.07；p=0.007）。组间非手术治疗与骨不愈合的发生独立相关（p=0.0001）。总的来说，切开复位内固定组在 1 年随访时的 DASH 评分（3.4 分比 6.1 分，p=0.04）和 Constant 评分（92.0 分比 87.8 分，p=0.01）均显著优于非手术治疗组。但当排除骨不愈合患者后，两组在任何时间点的 Constant 评分或 DASH 评分均无显著差异。切开复位内固定组患者对肩下垂、骨折部位局部凸起和肩部不对称的症状满意度较低（p<0.0001）。切开复位内固定组的治疗费用显著高于非手术治疗组（p<0.0001）。
与非手术治疗相比，切开复位内固定可降低急性移位锁骨中段骨折的骨不愈合率，并可改善功能结果。但这种改善可能源于切开复位内固定对骨不愈合的预防作用。切开复位内固定的费用较高，并与植入物相关并发症相关，而这些并发症在非手术治疗中并不常见。本研究结果不支持常规对移位锁骨中段骨折进行切开复位内固定治疗。
