Non-operative Versus Operative Treatment of Suprasyndesmotic Ankle Fractures: A Prospective, Multicentre, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Olerud-Molander Ankle Score (OMAS)
研究概览
简要总结
Weight-bearing radiographs will be used to evaluate the stability of suprasyndesmotic ankle fractures. Patients with stable fractures will be randomised to operative or non-operative treatment.
详细描述
Suprasyndesmotic fractures (Weber type C) are historically treated operatively because of the assumption that the distal tibiofibular syndesmosis is ruptured, leading to joint instability (Lauge-Hansen 1950, Boden 1989).
However, the medial deltoid ligament may function as the main stabiliser of the ankle joint by preventing external rotation of the talus and therefore maintains the dynamic congruity (Michelson 2007). Due to the stabilising effect of the deltoid ligament, an increasing number of transsyndesmotic fractures (Weber type B) are treated non-operatively with excellent results and without the burden of complications that accompany surgery (Gougoulias 2017, Mittal 2017, Bauer 1985).
The aims of the present study are to test the stability of suprasyndesmotic ankle fractures on weight-bearing radiographs and to evaluate the effect of non-operative versus operative treatment of stable suprasyndesmotic fractures.
The patients will have a weight-bearing (at least 50% of body weight) standing radiograph for the evaluation of the stability of the fracture. Patients with a congruent ankle mortise (i.e., stable fracture) on weight-bearing radiographs will be randomised to either operative (ORIF, reference treatment) or non-operative treatment (cast). Patients in both groups are allowed full weight-bearing.
Patients with an incongruent ankle mortise (i.e., unstable fracture) will be treated operatively according to current clinical practice and included in a parallel observational cohort study. Patients who are unwilling to participate in the intervention study are also invited to participate in the observational cohort study.
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
- Single (Outcomes Assessor)
盲法说明
Data will be plotted into a database by an independent blinded data manager.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who present with a closed, isolated fibular fracture classified as suprasyndesmotic (Weber C) with a medial clear space of less than 7 mm in mortise view on primary radiographs.
- •presentation less than 14 days after the injury.
排除标准
- •previous fractures or ligamentous injury to the injured ankle.
- •pathological fracture.
- •diabetic neuropathy or other neuropathies.
- •drug abuse.
- •inability to consent and/or comply.
- •inability to understand Norwegian language.
- •inability to walk unaided prior to the fracture.
- •patients with a concomitant tibial fracture requiring surgical treatment are excluded, but patients with undisplaced concomitant tibial fractures can be included.
- •patients from outside the catchment area of the recruiting hospitals. However, they can be included if they are willing to undergo follow-up visits at one of the recruiting hospitals.
结局指标
主要结局
Olerud-Molander Ankle Score (OMAS)
时间窗: The main statistical analysis of the primary outcome will be based on the two-year follow-up.
The primary outcome measure is the Olerud-Molander Ankle Score (OMAS), which is a condition-specific, patient-reported measure of ankle-fracture symptoms. OMAS ranges from 0 to 100, with higher scores indicating better outcomes and fewer symptoms.
次要结局
- Ankle pain(The main statistical analysis of the outcome will be based on the two-year follow-up.)
- Manchester-Oxford Foot Questionnaire (MOxFQ)(The main statistical analysis of the outcome will be based on the two-year follow-up.)
- EuroQol questionnaire (EQ-5D)(The main statistical analysis of the outcome will be based on the two-year follow-up.)
- Adverse events(The main statistical analysis of the outcome will be based on the two-year follow-up.)
- Radiographic results(The main statistical analysis of the outcome will be based on the two-year follow-up.)
- Range of motion(The main statistical analysis of the outcome will be based on the two-year follow-up.)