下肢骨折创伤患者的允许负重:前瞻性多中心比较队列研究。
Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.
作者信息
Kalmet Pishtiwan H S, Meys Guido, V Horn Yvette Y, Evers Silvia M A A, Seelen Henk A M, Hustinx Paul, Janzing Heinrich, Vd Veen Alexander, Jaspars Coen, Sintenie Jan Bernard, Blokhuis Taco J, Poeze Martijn, Brink Peter R G
机构信息
Department of Traumatology, Maastricht University Medical Center, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Adelante Rehabilitation Center, Hoensbroek, The Netherlands.
出版信息
BMC Surg. 2018 Feb 2;18(1):8. doi: 10.1186/s12893-018-0341-3.
BACKGROUND
The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study.
METHODS/DESIGN: The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery.
PRIMARY OUTCOME MEASURE
ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration.
DISCUSSION
This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol.
TRIAL REGISTRATION
The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.
背景
对于接受手术治疗的下肢关节周围或关节内骨折(即下肢(关节周围)或关节内骨折)患者,标准的术后护理治疗是不负重或部分负重。我们针对接受手术治疗的下肢骨折患者制定了一种早期允许负重的术后康复方案。在本方案中,我们希望在前瞻性比较队列研究中,将我们的早期允许负重方案与现有的非负重指南进行比较。
方法/设计:该研究是一项前瞻性多中心比较队列研究,将对比两种康复后护理治疗方法,即根据AO指南进行允许负重和非负重治疗。研究人群包括接受骨盆/髋臼手术治疗骨折或下肢手术治疗(关节周围)或关节内骨折的患者。纳入期为12个月。随访期为6个月,在基线、术后2周、6周、12周和26周进行测量。
主要观察指标
采用下肢功能量表评估日常生活活动能力。使用鞋垫压力测量系统测量的依从性结果变量包括峰值负荷和步长持续时间。
讨论
本研究将调查允许负重的术后护理方案的(成本)效益。结果将提供证据,证明允许负重方案是否比目前的非负重方案更有效。
试验注册
该研究已在荷兰试验注册中心注册(NTR6077)。注册日期:2016年9月1日。