Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Foot and Ankle Ability Measure (FAAM)
研究概览
简要总结
randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
详细描述
The objective of this prospective, randomized controlled trial is to determine if there are any adverse outcomes associated with immediate weight bearing as compared to non-weight bearing following first MTP joint fusion. The primary outcome measures will look at patient reported outcomes of pain and function. The secondary outcome measures will be the difference in the incidence of non-union, as well as adverse events/complications (malunion, wound complications, hardware complications, infection, stress fracture).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
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
- •Age 18 years or great
- •Medically fit for surgery
- •Patients diagnosed with condition for which a 1st MTP joint fusion is a surgical management option based on clinical examination and radiographs
- •Failed non-operative management (orthotics, bracing, Tylenol, NSAIDs, shoe-wear modification)
- •Surgery is for an isolated 1st MTP fusion
- •Able and willing to comply with follow up schedule and requirements
- •Capable of providing informed consent
排除标准
- •Age <18 years old
- •Surgical booking is for more than just 1st MTP fusion
- •Unable to comply with follow up schedule and requirements
- •Unable to provide informed consent
结局指标
主要结局
Foot and Ankle Ability Measure (FAAM)
时间窗: 6 months
Activities of Daily Living (ADL) Scored out of 100\\higher score indicates more function
Visual analogue scale(VAS)
时间窗: 12 weeks
patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
次要结局
- Radiographic healing(6 weeks)