Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Ankle Fractures
- 发起方
- Wake Forest University Health Sciences
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Functional Outcome
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
The purpose of this study is to compare outcomes of patients with an ankle fracture to those with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for patients sustaining ankle fracture dislocations are poorer than those without dislocation.
详细描述
Orthopaedic literature has very limited data regarding outcomes following ankle fracture dislocations. Increased knowledge of the long-term consequences of these injuries could usher in changes to treatment paradigms, potentially resulting in improved outcomes. Thirty patients will be enrolled into two arms of this prospective study: isolated ankle fractures and ankle fracture dislocations. Patients will be followed through their operative and postoperative course and clinical and radiographic assessments will be analyzed. We plan to compare the clinical, radiographic, and functional outcomes of patients with ankle fractures to those with ankle fracture-dislocations. We also plan to identify factors that contribute to or predict poor clinical, functional, and/or radiographic outcomes in patients with ankle fractures and fracture-dislocations.
研究者
入排标准
入选标准
- •Patients who sustain an isolated bi-malleolar or trimalleolar ankle fracture or an ankle fracture-dislocation requiring open reduction internal fixation
- •Patients ages 18 and over
- •The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
- •Open and closed fractures (excluding Gustilo grade 3)
- •English must be patient's primary language
排除标准
- •Previous injury or significant osteoarthritis to the affected ankle
- •Current ipsilateral or contralateral lower extremity injury with the exception of a contralateral ankle fracture or fracture-dislocation
- •Retained hardware from a previous injury at or around the tibia-talar joint of the affected extremity
- •Patients under the age of 18
- •History of inflammatory arthropathy
- •Traumatic Brain Injury or Spinal Cord Injury preventing weightbearing on the lower extremities
- •The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements
- •Patients with Gustilo grade 3B and 3C open fractures
结局指标
主要结局
Change in Functional Outcome
时间窗: 6, 12, and 24 months
Clinical and functional outcomes will be measured using the Foot and Ankle Ability Measure (FAAM) and the Short Form Musculoskeletal Functional Assessment (SMFA). Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.
次要结局
- Radiographic Outcome(24 month)