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Abstract：
OBJECTIVE: In this study, we aimed to compare the outcomes of the two-stage induced membrane technique (IMT) and one-stage autografting in the treatment of aseptic atrophic nonunion in lower limb long bones.
METHODS: From January 2014 to January 2022, we reviewed all surgically treated long bone nonunion patients, including patients aged 18 years or older with atrophic nonunion, who were either treated with the two-stage induced membrane technique (IMT) or one-stage autografting. Outcome parameters interns of clinical, quality of life and healthcare burden were recorded and retrospectively analysed between the two treatment populations. The follow-up time was at least 1 year.
RESULTS: In total, 103 patients who met the criteria for aseptic atrophic nonunion were enrolled. Among them, 41 (39.8%) patients were treated with two-stage IMT, and 62 (60.2%) patients were treated with one-stage autologous bone grafting. The follow-up time was 12 to 68 months, with an average of 28.4 months. The bone healing rate was comparable in both groups (IMT: 92.7% vs. one-stage grafting: 91.9%, P = 0.089) at 12 months post-operation, and the bone healing Lane-Sandhu score was superior in the IMT group (mean: 8.68 vs. 7.81, P = 0.002). Meanwhile, the SF-12 scores of subjective physical component score (PCS) (mean: 21.36 vs. 49.64, P < 0.01) and mental health component score (MCS) (mean: 24.85 vs. 46.14, P < 0.01) significantly increased in the IMT group, as well as in the one-stage grafting group, and no statistically significant difference was found within groups. However, the total hospital stays (median: 8 days vs. 14 days, P < 0.01) and direct medical healthcare costs (median: ¥30,432 vs. ¥56,327, P < 0.05) were greater in the IMT group, while the complications (nonunion 8, infection 3, material failure 2, and donor site pain 6) were not significantly different between the two groups (17.1% vs. 19.4, P = 0.770).
CONCLUSIONS: The data indicate that two-stage method of IMT serves as an alternative method in treating atrophic nonunion; however, it may not be a preferred option, in comprehensive considering patient clinical outcomes and healthcare burden. More evidence-based research is needed to further guide clinical decision-making.
METHODS: From January 2014 to January 2022, we reviewed all surgically treated long bone nonunion patients, including patients aged 18 years or older with atrophic nonunion, who were either treated with the two-stage induced membrane technique (IMT) or one-stage autografting. Outcome parameters interns of clinical, quality of life and healthcare burden were recorded and retrospectively analysed between the two treatment populations. The follow-up time was at least 1 year.
RESULTS: In total, 103 patients who met the criteria for aseptic atrophic nonunion were enrolled. Among them, 41 (39.8%) patients were treated with two-stage IMT, and 62 (60.2%) patients were treated with one-stage autologous bone grafting. The follow-up time was 12 to 68 months, with an average of 28.4 months. The bone healing rate was comparable in both groups (IMT: 92.7% vs. one-stage grafting: 91.9%, P = 0.089) at 12 months post-operation, and the bone healing Lane-Sandhu score was superior in the IMT group (mean: 8.68 vs. 7.81, P = 0.002). Meanwhile, the SF-12 scores of subjective physical component score (PCS) (mean: 21.36 vs. 49.64, P < 0.01) and mental health component score (MCS) (mean: 24.85 vs. 46.14, P < 0.01) significantly increased in the IMT group, as well as in the one-stage grafting group, and no statistically significant difference was found within groups. However, the total hospital stays (median: 8 days vs. 14 days, P < 0.01) and direct medical healthcare costs (median: ¥30,432 vs. ¥56,327, P < 0.05) were greater in the IMT group, while the complications (nonunion 8, infection 3, material failure 2, and donor site pain 6) were not significantly different between the two groups (17.1% vs. 19.4, P = 0.770).
CONCLUSIONS: The data indicate that two-stage method of IMT serves as an alternative method in treating atrophic nonunion; however, it may not be a preferred option, in comprehensive considering patient clinical outcomes and healthcare burden. More evidence-based research is needed to further guide clinical decision-making.
摘要：
目的：在本研究中，我们旨在比较两阶段诱导膜技术(IMT)和一阶段自体移植治疗下肢长骨无菌性萎缩性骨不连的疗效.
方法：从2014年1月到2022年1月，我们回顾了所有手术治疗的长骨骨不连患者，包括18岁或以上的萎缩性骨不连患者，接受两阶段诱导膜技术（IMT）或一阶段自体移植治疗的患者。临床实习生的结果参数，我们对两个治疗人群的生活质量和医疗负担进行了记录和回顾性分析.随访时间至少1年。
结果：总计，纳入103例符合无菌性萎缩性骨不连标准的患者。其中,41例（39.8%）患者接受两阶段IMT治疗，62例(60.2%)患者接受一期自体骨移植治疗。随访时间12～68个月,平均28.4个月。两组的骨愈合率相当(IMT:92.7%vs.一期嫁接：91.9%，P=0.089）术后12个月，IMT组的骨愈合Lane-Sandhu评分优于IMT组(平均值：8.68vs.7.81,P=0.002)。同时,SF-12主观身体成分得分(PCS)(平均值：21.36vs.49.64，P<0.01）和心理健康成分评分（MCS）（平均值：24.85vs.46.14，P<0.01）在IMT组中显着增加，以及在一期嫁接组中，组间差异无统计学意义。然而,总住院时间(中位数：8天vs.14天,P<0.01）和直接医疗保健费用（中位数：30,432日元vs.¥56,327，P<0.05）在IMT组中较大，而并发症（骨不连8，感染3，材料失效2和供体部位疼痛6）在两组之间没有显着差异（17.1%vs.19.4,P=0.770)。
结论：数据表明，IMT的两阶段方法是治疗萎缩性骨不连的替代方法；但是，这可能不是首选选择，综合考虑患者的临床结果和医疗负担。需要更多的循证研究来进一步指导临床决策。
方法：从2014年1月到2022年1月，我们回顾了所有手术治疗的长骨骨不连患者，包括18岁或以上的萎缩性骨不连患者，接受两阶段诱导膜技术（IMT）或一阶段自体移植治疗的患者。临床实习生的结果参数，我们对两个治疗人群的生活质量和医疗负担进行了记录和回顾性分析.随访时间至少1年。
结果：总计，纳入103例符合无菌性萎缩性骨不连标准的患者。其中,41例（39.8%）患者接受两阶段IMT治疗，62例(60.2%)患者接受一期自体骨移植治疗。随访时间12～68个月,平均28.4个月。两组的骨愈合率相当(IMT:92.7%vs.一期嫁接：91.9%，P=0.089）术后12个月，IMT组的骨愈合Lane-Sandhu评分优于IMT组(平均值：8.68vs.7.81,P=0.002)。同时,SF-12主观身体成分得分(PCS)(平均值：21.36vs.49.64，P<0.01）和心理健康成分评分（MCS）（平均值：24.85vs.46.14，P<0.01）在IMT组中显着增加，以及在一期嫁接组中，组间差异无统计学意义。然而,总住院时间(中位数：8天vs.14天,P<0.01）和直接医疗保健费用（中位数：30,432日元vs.¥56,327，P<0.05）在IMT组中较大，而并发症（骨不连8，感染3，材料失效2和供体部位疼痛6）在两组之间没有显着差异（17.1%vs.19.4,P=0.770)。
结论：数据表明，IMT的两阶段方法是治疗萎缩性骨不连的替代方法；但是，这可能不是首选选择，综合考虑患者的临床结果和医疗负担。需要更多的循证研究来进一步指导临床决策。
