Combined Randomised and Observational Study of Type B Ankle Fracture Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 21
- 主要终点
- PCS of Short Form (SF)-12v2
研究概览
简要总结
This study will determine whether operative management confers improved short and long-term outcomes for patients with isolated AO type 44-B1 distal fibula fractures when compared with non-operative management.
详细描述
Background:
Ankle fractures are common. Recent clinical studies have shown that there is an increasing incidence of ankle fractures. Treatments vary and there is no clear consensus of the ideal approach to type 44-B1 distal fibular fractures. They range from open reduction and internal fixation to restore anatomical alignment to wearing below-knee walking plaster for an average of six weeks.
The argument for surgical fixation is that it addresses minor displacement and possible future displacement therefore potentially preventing future arthritis. On the other hand, there are numerous complications associated with surgery.
The argument for non-operative treatment is that non-union is not a common complication. Therefore surgery can be avoided in the majority of cases avoiding the clinical risks associated with surgery.
Aim:
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
- •Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 44-B1 fibula fracture
- •Patients aged between 18 and 65 inclusive.
- •No talar shift - Medial clear space less than 2mm compared with the superior clear space on anterior-posterior (AP) view of the ankle.
- •Closed injury
- •No concurrent fractures/dislocations
- •Mobilising unaided/independently pre-injury
- •Willingness to be followed up for 12 months
- •Able to provide informed written consent
排除标准
- •Medically fit for general anaesthesia/surgery
- •Dislocation on presentation
- •Skeletally immature patients
- •Previous trauma or surgery to the affected ankle
- •Pregnancy
- •Other injuries that impede mobilisation e.g. stroke, neurovascular deficit at presentation
- •Non-English speaking
研究组 & 干预措施
Non-Operative
Patients who are treated non-operatively will be treated with a walking boot and allowed WBAT. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. All patients will be reviewed between 7 and 14 days post injury with repeat x-rays by the treating surgeon.
干预措施: Non Operative (Procedure)
Operative
The specific procedure for each patient managed operatively, both in the observational study and the RCT, will be determined by the operating surgeon. Any adverse intra-operative or post-operative event will be recorded. This includes but is not limited to death, infection and neurovascular injury. Post operatively, all patients will be NWB (non weight bearing) and placed in a POP (plaster of paris) below knee cast or walking boot. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. The treating surgeon will review the patients after 10-14 days for a wound review, removal of sutures and change of cast to a fibreglass cast or walking boot (cam walker). The patient will be WBAT (weight bearing as tolerated) for a further 4 weeks.
干预措施: Open reduction internal fixation of the ankle (Procedure)
结局指标
主要结局
PCS of Short Form (SF)-12v2
时间窗: 12 months
SF-12 version 2 Health Survey
American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire
时间窗: 12 months
American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire
次要结局
- MCS of Short Form (SF)-12v2(3, 6 and 12 months)
- PCS Short Form (SF)-12v2(3 and 6 months)
- Complications(6 weeks, 3, 6 and 12 months)
- American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire(3 and 6 months)
研究者
Rajat Mittal
Principal Investigator
The University of New South Wales