Chitnis Abhishek S, Ray Bidusee, Sparks Charisse, Grebenyuk Yuriy, Vanderkarr Mollie, Holy Chantal E
Real World Data Sciences, Medical Device Epidemiology, Johnson & Johnson, New Brunswick, NJ, USA.
Mu-Sigma, Bangalore, India.
Med Devices (Auckl). 2021 Feb 9;14:15-25. doi: 10.2147/MDER.S288188. eCollection 2021.
This study evaluated the rates and patterns of intramedullary nail (IMN) breakage and mechanical displacement for proximal femur fractures and the factors associated with their occurrence.
Patients with subtrochanteric, intertrochanteric, or basicervical femoral neck fractures treated with IMN from 2016 to 2019 were identified from commercial and Medicare supplemental claims databases and were followed for up to two years. Kaplan-Meier analysis estimated the cumulative incidence of and patterns of breakage/mechanical displacement. Multivariable Cox regression models evaluated the factors associated with breakage/mechanical displacement.
A total of 11,128 patients had IMN fixation for subtrochanteric, intertrochanteric, or basicervical femoral neck fractures: (mean SD) age 75.6 (16.4) years, 66.2% female, 74.3% Medicare supplemental vs 26.7% commercial insurance. Comorbidities included hypertension (62.9%), osteoporosis (27.3%), cardiac arrhythmia (23.1%), diabetes (30.7%), and chronic pulmonary disease (16.3%). Most fractures were closed (97.2%), intertrochanteric or basicervical femoral neck (80.1%), and not pathological (91.0%). The cumulative incidence of nail breakage over two years was 0.66% overall, 1.44% for combination fractures, 1.16% for subtrochanteric fractures, and 0.49% for intertrochanteric or basicervical fractures. The cumulative incidence of mechanical displacement was 0.37% overall, 0.43% for subtrochanteric fractures, 0.42% for combination fractures, and 0.36% for intertrochanteric or basicervical femoral neck fractures. Half of the breakages occurred within five months after surgery and half of the mechanical displacements occurred within 75 days. Age 50-64 (vs 75+) and subtrochanteric or pathological fracture were more commonly associated with nail breakage. Complicated hypertension was more commonly associated with mechanical displacement.
The incidence of IMN breakage and mechanical displacement in US commercial and Medicare supplemental patients with proximal femur fractures from 2016 to 2019 was low (0.66% and 0.37%, respectively up to two years). Age 50-64 (vs 75+) and subtrochanteric or pathological fracture were more commonly associated with breakage. Complicated hypertension was associated with mechanical displacement.
本研究评估了股骨近端骨折髓内钉(IMN)断裂和机械移位的发生率及模式,以及与它们发生相关的因素。
从商业和医疗保险补充索赔数据库中识别出2016年至2019年接受IMN治疗的转子下、转子间或股骨颈基底部骨折患者,并随访长达两年。Kaplan-Meier分析估计了断裂/机械移位的累积发生率及模式。多变量Cox回归模型评估了与断裂/机械移位相关的因素。
共有11128例患者接受了转子下、转子间或股骨颈基底部骨折的IMN固定:(均值±标准差)年龄75.6(16.4)岁,女性占66.2%,医疗保险补充患者占74.3%,商业保险患者占26.7%。合并症包括高血压(62.9%)、骨质疏松(27.3%)、心律失常(23.1%)、糖尿病(30.7%)和慢性肺病(16.3%)。大多数骨折为闭合性(97.2%),转子间或股骨颈基底部骨折(80.1%),且非病理性骨折(91.0%)。两年内髓内钉断裂的总体累积发生率为0.66%,合并骨折为1.44%,转子下骨折为1.16%,转子间或股骨颈基底部骨折为0.49%。机械移位的总体累积发生率为0.37%,转子下骨折为0.43%,合并骨折为0.42%,转子间或股骨颈基底部骨折为0.36%。一半的断裂发生在术后五个月内,一半的机械移位发生在75天内。50 - 64岁(对比75岁以上)以及转子下或病理性骨折更常与髓内钉断裂相关。复杂高血压更常与机械移位相关。
2016年至2019年美国商业保险和医疗保险补充保险的股骨近端骨折患者中,髓内钉断裂和机械移位的发生率较低(两年内分别为0.66%和0.37%)。50 - 64岁(对比75岁以上)以及转子下或病理性骨折更常与断裂相关。复杂高血压与机械移位相关。