Medial Malleolus: Operative or Non-operative - A Prospective Randomized Controlled Trial of Operative Versus Non-operative Management of Associated Medial Malleolus Fractures in Unstable Fracture Dislocations of the Ankle Joint'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Change in Olerud & Molander Ankle Score (OMAS) over a one-year post-operative period
研究概览
简要总结
Medial malleolus: Operative Or Non-operative (MOON study) Ankle fractures are a common Orthopaedic trauma presentation, accounting for approximately 10% of the workload. There has been debate regarding the significance of the contribution of the medial malleolus to ankle stability. Some deem the lateral malleolus as the key stabiliser. With this anatomically aligned the ankle joint should be stable. Operating on the medial malleolus fracture often requires a second generous skin incision, soft tissue stripping and insertion of metalwork. This carries with it the risk of wound complications, infection and increased operation time. High risk patients including the elderly, diabetics and those with significant swelling following injury are particularly vulnerable. The study will include adult patients (≥16 years) with capacity to consent and complete post-operative questionnaires, presenting to a single Orthopaedic trauma unit. Participants will be randomised to fixation or non-fixation of associated medial malleolus fractures at the same time as fixation of the lateral malleolar fracture to assess if this impacts on validated patient outcomes, failure, operative time and complications over a one-year follow-up. Only one trial has been published, showing no significant difference between failure rates or outcomes, but reduced operative time.
Participants will be enrolled into the trial following informed consent. The final decision on whether a participant is eligible can only be made during surgery when the medial malleolus fracture has reduced with no more than 2mm displacement. If this is confirmed the participant will be randomised to receive either fixation or non-fixation of the medial malleolus. Randomisation therefore occurs at the time of surgery. Participants will be reviewed at set post-operative checkpoints, with X-rays and patient reported outcome scores. Trial data will hopefully enable surgeons to make better informed decisions when managing patients with ankle fracture dislocations.
详细描述
This trial will include adult patients (16 years) presenting to the single centre; Edinburgh Orthopaedic Trauma Unit, Royal Infirmary of Edinburgh, with an isolated unstable fracture of the ankle joint requiring operative intervention. Both NHS research ethics committee (REC) approval and NHS R&D Management approval have been granted.
All patients will be treated in the Emergency Department (ED) with closed reduction and casting under procedural sedation and then referred to Orthopaedics via the on-call service. Patients will be considered for the trial if the following criteria are met:
- Aged 16 years or older.
- An unstable fracture dislocation of the ankle joint, defined as a bimalleolar or trimalleolar fracture pattern with or without any of the following:
- Radiographic evidence of talar shift
- Posterior malleolar fracture of >25% articular involvement or >2mm step-off
- Syndesmosis injury
Patients who consent to participate in the trial will be enrolled into the trial pre-operatively, but the result of their randomisation will not be revealed until after fibular fixation and assessment of medial malleolus reduction intra-operatively. Patients will only be eligible to continue in the trial if the medial malleolus reduces to acceptable limits without open reduction (≤2mm of displacement as seen on a radiographic antero-posterior view). If the medial malleolus fracture does not reduce within this 2mm limit, the patient will require formal open reduction and internal fixation and consequently not suitable to continue in the trial. The inclusion and exclusion criteria for this trial are displayed below.
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
盲法说明
There is no blinding possible in this trial as the presence or absence of medial sided surgery is obvious to both the surgeon and the patient due to the presence or absence of a skin incision.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥16 years
- •Able to consent to treatment
- •Unstable fracture dislocation of the ankle joint requiring operative intervention as defined in section 3.1
- •Closed injury
- •Weber B & Weber C fractures
- •Surgery date within two weeks of date of fracture
排除标准
- •Patients unable to comply with post-operative data gathering including completing questionnaires in English language
- •Additional lower limb injury, which may impact on patient rehabilitation
- •Open fracture
- •Confirmed severe associated neurovascular injuries
- •Distal tibial intra-articular fractures/ pilon type injuries
- •Supination-adduction type 2 (SAD-2) fracture configurations with a medial malleolus vertical shear fracture
- •Patients medically unfit for surgery
- •Patients declining operative management
- •Non-residents, unable to return to the unit for follow-up for a period of 1-year
- •Current engagement in a pharmaceutical/drug trial
- •Where the treating surgeon does not feel that inclusion in the trial is in the patients' best interest either due to the fracture pattern or patient factors
结局指标
主要结局
Change in Olerud & Molander Ankle Score (OMAS) over a one-year post-operative period
时间窗: 6 week, 3 months, 6 months and one year.
The OMAS is a functional rating scale developed in 1984, which has been used extensively as a research tool in foot and ankle surgery. It includes nine parameters: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living. The sub-score parameters are summated to generate a final score from 0 - 100, with '100' representing an excellent functional outcome and '0' being the worse possible outcome.
次要结局
- Tourniquet time(Immediately post-operatively)
- Change in Euroqol-5D over a one-year post-operative period(6 week, 3 months, 6 months and one year.)
- Change in Visual analogue pain scale (VAS) over a one-year post-operative period(6 week, 3 months, 6 months and one year.)
- Change in Manchester-Oxford Foot Questionnaire (MOXFQ) over a one-year post-operative period(6 week, 3 months, 6 months and one year.)
研究者
Tom Carter
Principle Investigagor
Royal Infirmary of Edinburgh