锁骨试验：一项比较手术与非手术治疗移位型锁骨中段骨折的多中心随机对照试验。
The Clavicle Trial: A Multicenter Randomized Controlled Trial Comparing Operative with Nonoperative Treatment of Displaced Midshaft Clavicle Fractures.
机构信息
1Department of Trauma and Orthopaedics, Royal Free Hampstead NHS Foundation Trust, London, United Kingdom 2Department of Statistical Science, University College London, London, United Kingdom.
出版信息
J Bone Joint Surg Am. 2017 Aug 16;99(16):1345-1354. doi: 10.2106/JBJS.16.01112.
BACKGROUND
The treatment of displaced midshaft clavicle fractures remains controversial.
METHODS
We undertook a multicenter randomized controlled trial to compare effectiveness and safety between nonoperative management and ORIF (open reduction and internal fixation) for displaced midshaft clavicle fractures in adults. Three hundred and one eligible adult patients were randomized to 1 of the 2 treatment groups and followed at 6 weeks, 3 months, and 9 months after recruitment. The primary outcome was the rate of radiographically evident nonunion at 3 months following treatment. Secondary outcomes were the rate of radiographically evident nonunion at 9 months, limb function measured using the Constant-Murley Score and DASH (Disabilities of the Arm, Shoulder and Hand) score, and patient satisfaction.
RESULTS
There was no difference in the proportion of patients with radiographic evidence of nonunion at 3 months between the operative (28%) and nonoperative (27%) groups, whereas at 9 months the proportion with nonunion was significantly lower (p < 0.001) in the operative group (0.8%) than in the nonoperative group (11%). The DASH and Constant-Murley scores and patient satisfaction were all significantly better in the operative group than in the nonoperative group at 6 weeks and 3 months.
CONCLUSIONS
Although at 3 months there was no evidence that surgery had reduced the rate of nonunion of displaced midshaft clavicle fractures, at 9 months nonoperative treatment had led to a significantly higher nonunion rate (11% compared with <1%). The rate of secondary surgical intervention during the trial period was 12 (11%) of the 147 patients in the nonoperative group. ORIF is a safe and reliable intervention with superior early functional outcomes and should be considered for patients who sustain this common injury.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
背景
移位型锁骨中段骨折的治疗仍存在争议。
方法
我们开展了一项多中心随机对照试验，比较了成人移位型锁骨中段骨折的非手术治疗与切开复位内固定（ORIF）的疗效和安全性。301 名符合条件的成年患者被随机分配到 2 种治疗组中的 1 种，并在招募后 6 周、3 个月和 9 个月进行随访。主要结局是治疗后 3 个月时影像学证实的不愈合率。次要结局是 9 个月时影像学证实的不愈合率、使用 Constant-Murley 评分和 DASH（手臂、肩部和手残疾）评分评估的肢体功能以及患者满意度。
结果
手术组（28%）和非手术组（27%）在 3 个月时影像学证实的不愈合患者比例无差异，而在 9 个月时手术组的不愈合比例明显更低（p<0.001）（0.8%）而非手术组（11%）。在 6 周和 3 个月时，手术组的 DASH 和 Constant-Murley 评分以及患者满意度均显著优于非手术组。
结论
虽然在 3 个月时，手术并未降低移位型锁骨中段骨折的不愈合率，但在 9 个月时，非手术治疗导致的不愈合率明显更高（11%比<1%）。在试验期间，非手术组中有 12 例（11%）患者需要进行二次手术干预。ORIF 是一种安全可靠的干预措施，具有较好的早期功能结局，对于发生这种常见损伤的患者应考虑采用。
证据等级
治疗性 I 级。详见作者说明以获取完整的证据等级描述。
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