Randomized Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 6
- 主要终点
- Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.
研究概览
简要总结
The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint.
The investigators hope to learn the following objectives from this study
- Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
- Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures.
Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ankle fractures that undergo open reduction internal fixation of the medial malleolus
排除标准
- •Tibial plafond (pilon) fractures
- •Medial malleolar osteotomies to access the talus, perform an ankle fusion, or deal with a pathologic lesion, osteonecrosis, or infection due to their diversity in diagnosis, management, and weight bearing status
- •Patients with prior surgical treatment of the ankle for fracture, deformity, infection, neoplasia, or other pathologic process on the ipsilateral extremity
- •Patients that are non-weight bearing on one or both lower extremities prior to sustaining their ankle injury
结局指标
主要结局
Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.
时间窗: Baseline, year 1
Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).
次要结局
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression(Baseline, year 2)
- Fracture Union Rate at One Year After Sustaining an Ankle Fracture.(Month 3)
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS)(Baseline, year 2)
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference(Baseline, year 2)
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function(Baseline, year 2)
- Amount Pain Medication Required During Recovery Period(Up to 2 years)
研究者
Derek Amanatullah
Assistant Professor, Dept of Orthopedic Surgery
Stanford University