A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- AOFAS Midfoot Scale
研究概览
简要总结
This trial is designed to compare different treatments on Lisfranc fractures. The trial consist of 2 different strata. Stratum 1: In mild injuries the comparison is between conservative treatment and operative treatment with open reduction and internal fixation (ORIF). Stratum 2: In severe injuries the comparison is between operative treatment with open reduction and internal fixation (ORIF) and primary arthrodesis. The primary outcome measure will be AOFAS Midfoot Score, and secondary outcome measure will be VAS Foot and Ankle.
详细描述
The aim of this study is to find out the most effective way to treat Lisfranc injuries
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nondislocated fractures affecting tarsometatarsal (TMT) joints II and III
- •Dislocation <5mm between medial cuneiforme and base of II metatarsal (MT)
- •No fractures affecting TMT joints IV and V
- •Affected joints TMT II- III + any other TMT
- •Any dislocation >2mm (fracture or TMT joint)
- •Dislocation >5mm between medial cuneiforme and base of II MT
排除标准
- •Open fractures
- •Extra-articular metatarsal (MT) fractures
- •Extremely comminuted fractures with bone loss, and slight chance of gaining proper reduction with screws
- •Patients with multiple fractures
- •Patients with weak co-operation (dementia, alcohol use, etc.)
- •Patients with significant neuropathy or some other neurological condition, diabetes and rheumatoid arthritis
- •Patients with severe circulatory disorder of the lower limb
- •Injuries over 14 days
- •Patients with previous foot injury or surgery
- •Pregnancy
- •Patients who refuse to participate
结局指标
主要结局
AOFAS Midfoot Scale
时间窗: 24 months
Between group difference in the functional outcome of the foot measured with AOFAS Midfoot Scale which is a subjective and objective evaluation of the midfoot based on questions in function (45 points), pain (40 points), and alignment (15 points) with a total score between 0 (worst score) and 100 (perfect score).
次要结局
- VAS Foot and Ankle(24 months)
- VAS Pain(24 months)
研究者
Heidi Haapasalo
MD, PhD
Tampere University Hospital