Stability and Outcomes of Non-displaced Lisfranc Injuries - A Prospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Manchester-Oxford Foot Questionnaire (MOxFQ)
研究概览
简要总结
In this multicenter cohort study, the stability of non-displaced Lisfranc injuries as well as their outcomes will be evaluated.
详细描述
Injuries to the tarsometatarsal joints ("Lisfranc injuries") that are non-displaced on non-weightbearing radiographs and CT are common injuries. To refer these injuries to the right treatment, evaluating their stability is essential. For this purpose, both weightbearing radiographs and stress fluoroscopy have been proposed. However, there is no consensus concerning both the use and interpretation of weightbearing radiographs and no standardized technique and interpretation of stress fluoroscopy in non-displaced Lisfranc injuries.
In the current study, participants will be assigned to non-operative or operative treatment based on Lisfranc joint stability evaluation by weightbearing radiographs.
All Patients with negative weightbearing radiographs will be treated conservatively. In addition, their injured feet will be evaluated by manual stress fluoroscopy. Depending on the result of the stress fluoroscopy (positive/negative), the conservatively treated patients will be assigned to 2 cohorts, whose outcomes will be compared.
Patients with positive weightbearing radiographs will be treated operatively by minimally invasive stabilization of the midfoot (eg. isolated "homerun screw"). The operatively treated patients will be followed up as an independent cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participants will be blinded for the result of the stress fluoroscopy.
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
- •Acute Lisfranc injuries that are non-displaced (< 2mm) on non-weightbearing radiographs and CT
- •Patients between 18 and 70 years of age
- •Acute presentation at one of our departments, enabling evaluating the stability of the injuries within 4 weeks
排除标准
- •Fractures with an intraarticular step of > 2mm on the initial non weight-bearing radiographs and/or CT
- •Delayed presentation (weight-bearing radiographs taken > 4 weeks after injury)
- •Bilateral injuries
- •Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process
- •Multitraumized patients
- •Previous injury or surgery of the mid foot
- •Charcot foot
- •Noncompliant patients
- •Insufficient Norwegian or English language skills
- •Patients not available for follow-up
- •Inability to conduct the rehabilitation protocol
研究组 & 干预措施
Negative WB radiographs and stress fluoroscopy
Cohort 1
Negative weight bearing radiographs:
Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side.
Negative stress fluoroscopy: the midfoot is tested stable
干预措施: Conservative treatment (Procedure)
Negative WB radiographs / positive stress fluoroscopy
Cohort 2
Negative weight bearing radiographs:
Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side.
Positive stress fluoroscopy: manual testing reveals midfoot instability
干预措施: Conservative treatment (Procedure)
Surgical cohort (Cohort 3)
Patients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort.
干预措施: Minimally invasive stabilization of Lisfranc injuries (Procedure)
结局指标
主要结局
Manchester-Oxford Foot Questionnaire (MOxFQ)
时间窗: 5 years
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
次要结局
- Incidence of complications(5 years)
- Visual Analogue Scale (VAS) for pain(5 years)
- Short-Form (SF) 36(5 years)
- Posttraumatic osteoarthritis(5 years)
- American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score(5 years)
- Self-reported foot and ankle score (SEFAS)(5 years)