NCT05151926招募中不适用
Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture (LIMPER-TSF): a Protocol for Prospective, Randomized,Multicentre Trial Comparing the Early Partial and Early Full Weightbearing After Nailed Tibial Shaft Fracture
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Return to work
研究概览
简要总结
Aim of our study is to compare immediate full weight-bearing and partial weight-bearing for 6 weeks after a tibial shaft fracture treated with intramedullary nailing. Co-primary outcome is return to work and physical component scale in the SF-36 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AO/OTA 42-A/B acute, noncomminuted diaphyseal fracture of the tibia treated with intramedullary nailing with or without posterior malleolus screw fixation
- •operated within 72 hours of admittance
- •age between 18-65 years
排除标准
- •the inability to fill out the Finnish versions of the questionnaires
- •previous arthroplasty of the knee or the ankle of the fractured limb
- •previous ipsilateral below-knee fracture requiring surgical treatment or ankle arthrodesis
- •inability to co-operate
- •not living independently (institutionalized living before fracture)
- •open fracture (Gustilo grade 2 or over)
- •pathologic or stress fracture
- •multiple fractures requiring operative treatment in polytrauma patient
- •severe medical comorbidity impairing daily activities (inability to go climb three floors without assistance and stopping)
- •Body Mass Index over 40
- •unacceptably high risk of surgery due to severe medical comorbidities
- •severe substance abuse
- •patient is retired
- •age is less than 18 or more than 65
- •patient required a fasciotomy due to acute compartment syndrome during or after index surgery
- •inability to walk before fracture or a daily need of walking aid, such as crutches
研究组 & 干预措施
Partial-weight bearing
Active Comparator
Partial weight-bearing for the first 6 weeks postoperatively.
干预措施: Intramedullary nailing (Procedure)
Full weight-bearing
Experimental
Full immediate weight-bearing postoperatively
干预措施: Full weight-bearing (Procedure)
Full weight-bearing
Experimental
Full immediate weight-bearing postoperatively
干预措施: Intramedullary nailing (Procedure)
Partial-weight bearing
Active Comparator
Partial weight-bearing for the first 6 weeks postoperatively.
干预措施: Partial weight-bearing (Procedure)
结局指标
主要结局
Return to work
时间窗: 3 months
Rate of return to work
Physical component summary
时间窗: 3 months
Physical component summary of the SF-36 questionnaire
次要结局
- Return to work(12 months)
- Physical component summary(12 months)
- 36-Item Short Form Survey(24 months)
- Total sick leave(12 months)
- Tegner activity level scale(24 months)
- Lower extremity functional scale(24 months)
- University of California and Los Angeles activity level scale(24 months)
- Complications(24 months)
- Return to work(6 months)
- Physical component summary(6 months)
- Lower extremity functional scale(3 months)
- Lower extremity functional scale(6 months)
- Tegner activity level scale(6 months)
- Complications(6 months)
- Lower extremity functional scale(12 months)
- 36-Item Short Form Survey(3 months)
- 36-Item Short Form Survey(6 months)
- 36-Item Short Form Survey(12 months)
- Tegner activity level scale(3 months)
- Tegner activity level scale(12 months)
- University of California and Los Angeles activity level scale(3 months)
- University of California and Los Angeles activity level scale(6 months)
- University of California and Los Angeles activity level scale(12 months)
- Complications(6 weeks)
- Complications(3 months)
- Complications(12 months)
研究者
Aleksi Reito
Associate professor
Tampere University Hospital
研究点 (3)
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