Abstract：
BACKGROUND: Obesity is increasing. Previous studies have demonstrated an association between obesity and adverse events after lumbar fusion. There is limited evidence on the effect of obesity on minimally invasive SI joint fusion (SIJF) outcomes.
OBJECTIVE: The purpose of this study was to investigate the impact of obesity on patient-reported outcomes in patients undergoing SIJF surgery using triangular titanium implants (TTI).
METHODS: Retrospective cohort study based on four prospective clinical trials (INSITE [NCT01681004], SIFI [NCT01640353], iMIA [NCT01741025], and SALLY [NCT03122899]).
METHODS: Adult patients ≥18 years of age who underwent minimally invasive surgery (MIS) sacroiliac joint (SIJ) fusion between 2012 and 2021.
METHODS: Visual analog scale (VAS Pain), Oswestry Disability Index (ODI).
METHODS: Participants were classified using the National Institutes of Health body mass index (BMI). Patients with a BMI of 30 to 39 with no significant comorbidity are considered obese, patients with a BMI of 35 to 39 with a significant comorbidity or a BMI of 40 or greater are considered morbidly obese. All subjects underwent either minimally invasive SIJ fusion with TTI or nonsurgical management (INSITE and iMIA studies only). All subjects completed SIJ pain scale scores (measured with a 100-point VAS) and disability scores (measured with ODI) at baseline and at scheduled visits to 24 months. Repeated measures analysis of variance was used to examine the impact of BMI category on score changes.
RESULTS: In the SIJF group, mean SIJ pain improved at 24 months by 53.3 points (p<.0001). Over the 24-month follow-up period, BMI category did not impact mean improvement in SIJ pain scale score (repeated measures analysis of variance (ANOVA) p=.44). In the SIJF group, mean ODI at 24 months improved by 25.8 points (p<.0001). BMI category did not impact mean improvement in ODI (ANOVA p=.60). In the nonsurgical management (NSM) group, mean improvements in SIJ pain scale and ODI were clinically small (8.7 and 5.2 points, respectively) and not affected by BMI category (ANOVA p=.49 and .40).
CONCLUSIONS: This study demonstrates similar benefits and risks of minimally invasive SIJ fusion with TTI across all BMI categories. This analysis suggests that obese patients benefit from minimally invasive SIJ fusion and should not be denied this procedure based solely on elevated BMI.
OBJECTIVE: The purpose of this study was to investigate the impact of obesity on patient-reported outcomes in patients undergoing SIJF surgery using triangular titanium implants (TTI).
METHODS: Retrospective cohort study based on four prospective clinical trials (INSITE [NCT01681004], SIFI [NCT01640353], iMIA [NCT01741025], and SALLY [NCT03122899]).
METHODS: Adult patients ≥18 years of age who underwent minimally invasive surgery (MIS) sacroiliac joint (SIJ) fusion between 2012 and 2021.
METHODS: Visual analog scale (VAS Pain), Oswestry Disability Index (ODI).
METHODS: Participants were classified using the National Institutes of Health body mass index (BMI). Patients with a BMI of 30 to 39 with no significant comorbidity are considered obese, patients with a BMI of 35 to 39 with a significant comorbidity or a BMI of 40 or greater are considered morbidly obese. All subjects underwent either minimally invasive SIJ fusion with TTI or nonsurgical management (INSITE and iMIA studies only). All subjects completed SIJ pain scale scores (measured with a 100-point VAS) and disability scores (measured with ODI) at baseline and at scheduled visits to 24 months. Repeated measures analysis of variance was used to examine the impact of BMI category on score changes.
RESULTS: In the SIJF group, mean SIJ pain improved at 24 months by 53.3 points (p<.0001). Over the 24-month follow-up period, BMI category did not impact mean improvement in SIJ pain scale score (repeated measures analysis of variance (ANOVA) p=.44). In the SIJF group, mean ODI at 24 months improved by 25.8 points (p<.0001). BMI category did not impact mean improvement in ODI (ANOVA p=.60). In the nonsurgical management (NSM) group, mean improvements in SIJ pain scale and ODI were clinically small (8.7 and 5.2 points, respectively) and not affected by BMI category (ANOVA p=.49 and .40).
CONCLUSIONS: This study demonstrates similar benefits and risks of minimally invasive SIJ fusion with TTI across all BMI categories. This analysis suggests that obese patients benefit from minimally invasive SIJ fusion and should not be denied this procedure based solely on elevated BMI.
摘要：
背景：肥胖正在增加。先前的研究表明，肥胖与腰椎融合后的不良事件之间存在关联。关于肥胖对微创SI关节融合（SIJF）结局的影响的证据有限。
目的：本研究的目的是研究肥胖对使用三角形钛植入物（TTI）进行SIJF手术的患者报告结局的影响。
方法：基于四项前瞻性临床试验的回顾性队列研究(INSITE[NCT01681004]，SFI[NCT01640353],iMIA[NCT01741025],andSALLY[NCT03122899]).
方法：在2012年至2021年之间接受微创手术（MIS）骶髂关节（SIJ）融合的年龄≥18岁的成年患者。
方法：视觉模拟量表（VAS疼痛），Oswestry残疾指数(ODI)。
方法：使用美国国立卫生研究院体重指数（BMI）对参与者进行分类。BMI为30至39且无明显合并症的患者被认为是肥胖，BMI为35~39且有显著合并症或BMI为40或更高的患者被认为是病态肥胖.所有受试者均接受了带TTI的微创SIJ融合或非手术治疗（仅限INSITE和iMIA研究）。所有受试者在基线和24个月的预定访视时完成SIJ疼痛量表评分(用100点VAS测量)和残疾评分(用ODI测量)。重复测量方差分析用于检查BMI类别对得分变化的影响。
结果：在SIJF组中，平均SIJ疼痛在24个月时改善了53.3分（p<.0001）。在24个月的随访期间，BMI类别不影响SIJ疼痛量表评分的平均改善（重复测量方差分析（ANOVA）p=0.44）。在SIJF组中,24个月时的平均ODI提高了25.8个百分点（p<0.0001）。BMI类别不影响ODI的平均改善（方差分析p=0.60）。在非手术管理(NSM)组中，SIJ疼痛量表和ODI的平均改善在临床上较小(8.7和5.2分，分别)，不受BMI类别影响(方差分析p=.49和.40)。
结论：这项研究表明，在所有BMI类别中，采用TTI的微创SIJ融合具有相似的益处和风险。此分析表明，肥胖患者受益于微创SIJ融合，不应仅基于BMI升高而拒绝此手术。
目的：本研究的目的是研究肥胖对使用三角形钛植入物（TTI）进行SIJF手术的患者报告结局的影响。
方法：基于四项前瞻性临床试验的回顾性队列研究(INSITE[NCT01681004]，SFI[NCT01640353],iMIA[NCT01741025],andSALLY[NCT03122899]).
方法：在2012年至2021年之间接受微创手术（MIS）骶髂关节（SIJ）融合的年龄≥18岁的成年患者。
方法：视觉模拟量表（VAS疼痛），Oswestry残疾指数(ODI)。
方法：使用美国国立卫生研究院体重指数（BMI）对参与者进行分类。BMI为30至39且无明显合并症的患者被认为是肥胖，BMI为35~39且有显著合并症或BMI为40或更高的患者被认为是病态肥胖.所有受试者均接受了带TTI的微创SIJ融合或非手术治疗（仅限INSITE和iMIA研究）。所有受试者在基线和24个月的预定访视时完成SIJ疼痛量表评分(用100点VAS测量)和残疾评分(用ODI测量)。重复测量方差分析用于检查BMI类别对得分变化的影响。
结果：在SIJF组中，平均SIJ疼痛在24个月时改善了53.3分（p<.0001）。在24个月的随访期间，BMI类别不影响SIJ疼痛量表评分的平均改善（重复测量方差分析（ANOVA）p=0.44）。在SIJF组中,24个月时的平均ODI提高了25.8个百分点（p<0.0001）。BMI类别不影响ODI的平均改善（方差分析p=0.60）。在非手术管理(NSM)组中，SIJ疼痛量表和ODI的平均改善在临床上较小(8.7和5.2分，分别)，不受BMI类别影响(方差分析p=.49和.40)。
结论：这项研究表明，在所有BMI类别中，采用TTI的微创SIJ融合具有相似的益处和风险。此分析表明，肥胖患者受益于微创SIJ融合，不应仅基于BMI升高而拒绝此手术。
