BACKGROUND This study compared outcomes at 18 months between patients who underwent transtibial amputation with and without a tibiofibular synostosis procedure. We hypothesized that complication rates would be lower in patients who did not receive a synostosis procedure compared with those who did receive a synostosis procedure, but the synostosis group would report better function. METHODS This multicenter randomized clinical trial (RCT) included patients aged 18 to 60 years who were treated without (n = 52) or with synostosis (n = 54) during transtibial amputation. Patients who refused randomization were enrolled in an observational (OBS) study (n = 93; 31 synostosis, 62 non-synostosis). There were 2 primary outcomes: operative treatment for a complication within 18 months of amputation and Short Musculoskeletal Function Assessment (SMFA) scores. The primary analyses were based on the RCT participants, and the secondary analyses were based on the treatment received by the combined RCT + OBS participants. RESULTS In the primary RCT analysis, the probability of ≥1 operatively treated complication was higher for the synostosis group (42%; 95% confidence interval [CI]: 29.8% to 56.2%) than the non-synostosis group (24%; 95% CI: 14.2% to 37.9%), with an absolute risk difference of 18% (95% CI: 0.31% to 36%). There were no appreciable differences in mean SMFA scores. In the secondary combined analysis, the probability of an operatively treatment complication was larger in patients who did versus did not receive a synostosis procedure (absolute risk difference: 26.1%; 95% CI: 12.0% to 40.3%). Differences in SMFA scores favored synostosis, although there were no differences in pain, prosthetic use, and satisfaction. CONCLUSIONS The results of the primary RCT analysis supported our hypothesis of fewer complications in patients who do not undergo a synostosis procedure compared with those who undergo a synostosis procedure, but we found insufficient evidence to conclude that those in the synostosis group have better function. The trial did not reach target enrollment. The secondary combined analysis supported the primary analysis in terms of complications. In the secondary analysis, while pain, prosthetic use, and satisfaction remained similar, the SMFA scores were better for the patients who received a synostosis procedure, although the differences are of uncertain clinical importance. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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有和没有胫腓早闭手术的胫骨截肢后的结局：一项多中心随机临床试验（TAOS 研究）。


背景 本研究比较了接受胫胫截肢术和不进行胫腓早闭手术的患者在 18 个月时的结局。我们假设与接受缝闭手术的患者相比，未接受缝闭手术的患者并发症发生率较低，但缝闭组报告功能更好。方法 这项多中心随机临床试验 （RCT） 包括年龄在 18 至 60 岁之间的患者，他们在胫骨截肢术中接受治疗未接受 （n = 52） 或有粘连治疗 （n = 54）。拒绝随机分组的患者被纳入一项观察性 （OBS） 研究 （n = 93;31 例粘连，62 例非粘连）。有 2 个主要结局： 截肢后 18 个月内并发症的手术治疗和短肌肉骨骼功能评估 （SMFA） 评分。主要分析基于 RCT 参与者，次要分析基于 RCT + OBS 联合参与者接受的治疗。结果 在主要 RCT 分析中，关节早闭组 （42%;95% 置信区间 [CI]： 29.8% 至 56.2%） 手术治疗并发症≥的可能性高于非早闭组 （24%;95% CI： 14.2% 至 37.9%），绝对风险差异为 18% （95% CI： 0.31% 至 36%）。平均 SMFA 评分无明显差异。在二次联合分析中，接受缝闭手术的患者与未接受缝闭手术的患者发生手术治疗并发症的可能性更大（绝对风险差：26.1%;95% CI：12.0% 至 40.3%）。SMFA 评分的差异有利于缝合，尽管在疼痛、假体使用和满意度方面没有差异。 结论 主要 RCT 分析的结果支持我们的假设，即与接受缝闭手术的患者相比，未接受缝合手术的患者并发症更少，但我们发现没有足够的证据得出结论，即缝合组的患者功能更好。该试验未达到目标入组率。次要联合分析在并发症方面支持主要分析。在二次分析中，虽然疼痛、修复体使用和满意度保持相似，但接受关节粘连手术的患者的 SMFA 评分更好，尽管这些差异的临床重要性不确定。证据级别 治疗 I 级。有关证据级别的完整描述，请参阅作者说明。