Acute Achilles tendon rupture - Minimally invasive surgery versus nonoperative treatment with immediate full weightbearing - Randomized controlled trial

Acute Achilles tendon rupture - Minimally invasive surgery versus nonoperative treatment with immediate full weightbearing - Randomized controlled trial
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DOI:
10.1177/0363546508319312
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发表时间:
2008-09-01
影响因子:
4.8
通讯作者:
van der Werken, Christiaan
van der Werken, Christiaan
中科院分区:
医学1区
文献类型:
--
作者:
Metz, Roderick;Verleisdonk, Egbert-Jan M. M.;van der Werken, Christiaan

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背景资料:急性跟腱断裂的手术修复被认为是上级的非手术治疗,但并发症以外的再断裂的范围高达34%。功能性支具的非手术治疗似乎是一个有前途的选择。假设:与微创技术手术治疗相比,功能性支具的非手术治疗急性跟腱断裂可减少并发症的数量。研究设计:随机对照临床试验;证据等级,2.方法:采用隐蔽随机分配法,将83例急性跟腱断裂患者分为功能性支具非手术治疗组和微创手术治疗组。患者被允许完全负重,随访1 year.Results:其他并发症的风险比再破裂的意向治疗基础是9 42例(21%)的手术治疗和15 41例(36%)的非手术治疗(风险比,0.59; 95%置信区间,0.29-1.19)。41例非手术治疗患者中有5例复发,42例手术治疗患者中有3例复发(风险比,0.59; 95%可信区间,0.15-2.29)。手术治疗后平均工作时间为59天(SD,82),非手术治疗后平均工作时间为108天(SD,115)(差异为49天; 95%置信区间,4-94; P <0.05)。回归运动的治疗方法之间的差异(风险比,0.55; 95%可信区间,0.23-1.29)、疼痛和治疗满意度未达到统计学显著性。急性跟腱断裂的微创手术治疗和非手术治疗之间的并发症风险似乎存在临床重要差异,但这在统计学上并不显著。
Background: Surgical repair of acute Achilles tendon ruptures is considered superior to nonoperative treatment, but complications other than rerupture range up to 34%. Nonoperative treatment by functional bracing seems a promising alternative.Hypothesis: Nonoperative treatment of acute Achilles tendon rupture with functional bracing reduces the number of complications compared with surgical treatment with a minimally invasive technique.Study Design: Randomized controlled clinical trial; Level of evidence, 2.Method: Using concealed random allocation, 83 patients with acute Achilles tendon rupture were assigned to nonoperative treatment by functional bracing or minimally invasive surgical treatment followed by tape bandage. Patients were allowed full weightbearing, and follow-up was 1 year.Results: Complications risk other than rerupture by intention-to-treat basis was 9 in 42 patients (21%) for surgical treatment and 15 in 41 patients (36%) for nonoperative treatment (risk ratio, 0.59; 95% confidence interval, 0.29-1.19). Reruptures risk was 5 in 41 patients after nonoperative treatment and 3 in 42 patients for surgical treatment (risk ratio, 0.59; 95% confidence interval, 0.15-2.29). The mean time to work was 59 days (SD, 82) after surgical treatment and 108 days (SD, 115) after nonoperative treatment (difference, 49 days; 95% confidence interval, 4-94; P < .05). The difference between treatments for return to sports (risk ratio, 0.55; 95% confidence interval, 0.23-1.29), pain, and treatment satisfaction did not reach statistical significance.Conclusion: There appears to be a clinically important difference in the risk of complications between minimally invasive surgical treatment and nonoperative treatment for acute Achilles tendon ruptures, but this was not statistically significant.