Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture Following Early Mobilization Nonoperative Treatment or Operative Treatment With Screw Fixation - a Noninferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Grip strength
研究概览
简要总结
Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with operation. With minimal displacement this fracture is usually treated with immobilisation or early mobilisation. With appreciable displacement especially any malrotation the patient usually is treated with an operation. This usually includes an open reduction of the fracture and fixation with plates and screws or just screws.
The hypothesis that nonoperative treatment (using early mobilization without splintage) will result in similar outcomes to operative treatment was previously tested by this research group (Peyronson et al. JBJS American 2023). Over a 1-year follow-up the primary outcome of grip strength was found to be noninferior.
This trial will extend the follow-up period and re-evaluate the patients included in the original cohort to identify any difference over a 3-6 year follow up.
详细描述
The original trial was a noninferiority randomized controlled trial evaluating 42 patients. Randomization was performed 1:1 to either nonoperative treatment with mobilization initiated immediately following recruitment or operative treatment using ORIF with cortical screws or locking compression plate (LCP) and screw fixation.
The non-inferiority margin (NIM) was defined as -15% grip strength of the injured hand relative to the contralateral hand. The same NIM will be used for this trial.
Because subtle biomechanical changes (mainly metacarpal bone shortening) could theoretically cause problems not evident at 1-year follow-up (such as joint degeneration from changes in load distribution), the investigators plan to re-evaluate the patients for a longer-term follow-up.
Only patients included in the original trial will be eligible for inclusion in this extended follow-up. Participation will be offered via mail invitation, and participants will be offered financial compensation in the form of a single payment of 500SEK.
Data collection will be performed in a single outpatient hospital visit where patient history, subjective outcome data and bilateral plain radiography of the hands will be obtained.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous inclusion in the original study population, i.e.:
- •Diaphyseal, single spiral, and oblique fractures of the index to little finger metacarpals
- •Fracture line length at least twice the diameter of the bone at the level of the fracture
- •At least 2-mm displacement and/or shortening of the fracture or malrotation
- •Normal hand function before the injury
- •Fracture <10 days old
排除标准
- •Multiple metacarpal fractures
- •Open fractures
- •Inability to follow instructions
- •Fracture line length less than twice the diameter of the bone at the level of the fracture
- •Abnormal hand function before the injury
- •Previous ipsilateral hand fractures
- •Fracture ≥10 days old at possible randomization
结局指标
主要结局
Grip strength
时间窗: 3-6 years
Grip strength is measured in both hands using a JAMAR dynamometer set to 2nd position with the patient sitting down, arm resting in 90 degree elbow flexion and neutral forearm rotation. Three measurements are taken in each arm and the mean value calculated. The strength of the injured hand is expressed as a percentage value relative to the strength of the contralateral (uninjured) hand.
次要结局
- DASH score(3-6 years)
- Metacarpal shortening(3-6 years)
- Rotation(3-6 years)
- Subjective pain(3-6 years)
- Subjective cosmetic result(3-6 years)
- Subjective overall result(3-6 years)
- Time off work(3-6 years)
- Range of motion(3-6 years)