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临床试验/NCT05799807
NCT05799807进行中(未招募)不适用

Weight-bearing Diagnostics in Acute Lisfranc Injury: A Prospective Study Comparing Computed Tomography Versus Conventional Radiography

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
38
试验地点
2
主要终点
Manchester-Oxford Foot Questionnaire (MOxFQ)

研究概览

简要总结

A prospective, cohort study comparing weight-bearing computed tomography with weight-bearing radiography in patients with an acute Lisfranc injury.

详细描述

Injury to the tarsometatarsal (TMT) joint complex in the midfoot is referred to as a Lisfranc injury. The broad spectrum of these injuries includes simple sprains to severe fracture-dislocations. Variable clinical presentations and radiographic findings make Lisfranc injuries notoriously difficult to detect, especially in the case of subtle ligament injuries. Nowadays, up to 30% of unstable Lisfranc injuries are overlooked or misdiagnosed. This can potentially lead to severe sequelae such as post-traumatic osteoarthritis and foot deformities.

For obvious injuries involving diastasis, subluxation, or dislocation, the diagnosis is relatively easy to establish using any imaging modality. However, for subtle injuries without gross bone separation, a dynamic imaging modality facilitating weight-bearing are to be preferred. Many consider weight-bearing conventional radiography as the current gold standard in acute Lisfranc injury diagnostics. However, conventional radiography is a 2D technique that can neither display nor measure the true dimensions of a detailed 3D object, such as the tarsal bones in the foot. Computed tomography (CT) provides greater accuracy in visualizing bone microarchitecture. In combination with weight-bearing, it can be ideal for detecting minor fractures and occult instability caused by load/stress.

To this day, there are no prospective studies comparing weight-bearing CT and weight-bearing radiography for acute Lisfranc injuries. In the current study, participants will be assigned to non-operative or operative treatment based on Lisfranc joint stability evaluation by the initial weight-bearing CT.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

入选标准

  • Acute trauma to the midfoot
  • Intraarticular fracture and/or avulsion fracture in the TMT joint line (detected on a non-weight-bearing CT)
  • Suspicion of a purely ligamentous Lisfranc injury (no radiological fractures but substantial clinical findings in the midfoot region, or evidence of ligamentous damage on a MRI)
  • Consent-competent patient

排除标准

  • Obvious acute unstable Lisfranc injuries (>2mm dislocation between the medial cuneiform and second metatarsal)
  • Injury older than four weeks
  • Other major foot/ankle/leg injuries
  • Previous foot infection or foot pathology on the affected side
  • Previous surgery to the TMT joints, and sequelae after a previous foot injury
  • Open injury
  • Bilateral injury
  • Patients with co-morbidities such as neuropathy and peripheral vascular disease

结局指标

主要结局

Manchester-Oxford Foot Questionnaire (MOxFQ)

时间窗: 1 year

Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)

次要结局

  • American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score(1 year)
  • Posttraumatic osteoarthritis(1 year)
  • Incidence of complications(1 year)
  • Visual Analogue Scale (VAS) for pain(1 year)
  • Short-Form (SF) 36(1 year)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magnus Poulsen

Principal Investigator

Oslo University Hospital

研究点 (2)

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