NCT05765929招募中不适用
Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
Ostfold Hospital Trust2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Olerud Molander Score (OMAS) to measure a change over time
研究概览
简要总结
The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
- •With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
- •With fractures in the distal 1/3 of fibula (not-Maisonneuve)
- •Enabling stability evaluation within 14 days after injury
- •18-75 years of age
- •with pre-injury walking ability without aids
排除标准
- •- With primary unstable ankle fractures, > 7mm medial clear space on primary radiographs
- •With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
- •With type A medial malleolus avulsion fractures < 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
- •With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
- •With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
- •With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
- •That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
- •With previous history ipsilateral ankle fracture
- •With previous history ipsilateral major ankle-/foot surgery
- •Who live outside the hospital catchment areas not available to follow up
- •With insufficient Norwegian or English language skills
- •Non-compliant
结局指标
主要结局
Olerud Molander Score (OMAS) to measure a change over time
时间窗: 6 week, 12 weeks, 1year, 2 years
Condition specific, patient reported measure of ankle-fracture symptoms
次要结局
- Posttraumatic osteoarthritis (OA)(2 years and 5 years)
- Manchester-Oxford Foot Questionnaire (MOxFQ)(6 week, 12 weeks, 1year, 2 years)
- Range of Motion measured by a goniometer (ad modum Lindsjo)(6 week, 12 weeks, 1year, 2 years)
- Euroqol questionnaire (EQ- 5D)(6 week, 12 weeks, 1year, 2 years)
- Registrations of complications/adverse events(0-2 years)
- Numeric Rating Scale (NRS)(6 week, 12 weeks, 1year, 2 years)
研究者
研究点 (2)
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