A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TAM (Total active range of motion)
研究概览
简要总结
This study aims at investigating if splinting and early mobilization is a better method, regarding range of motion, for treating fractures of the base phalanx of the fingers compared to surgery with pinning. This will be achieved through a randomised clinical trial comparing the two methods.
详细描述
Proximal phalangeal fractures of the hand are very common and affect patients of all ages. . Most fractures heal without complications but these injuries can result in impaired hand function and prolonged inability to work and perform activities of daily living. If there is a dislocation that cannot easily be repositioned to a stable position, surgery might be required. Surgery is often performed with percutaneous pinning and immobilisation in plaster for 4 weeks. Good results of non-surgical treatment with a splint that allows immediate mobilization of the interphalangeal joints has been reported. This study will compare these two methods for treating fractures of the base phalanx of the fingers. Recruited patients will be randomized to one of the two treatment arms: 1. surgery with pinning 2. conservative treatment with a splint. Primary outcome is total active range of motion in the affected finger at 3, 6 months and 1 , 3 years. Secondary outcomes are number of sick days and various patient related outcome measures.
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
- Single (Outcomes Assessor)
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
- •Fractures of the base phalanx of digit 2-5 in the hand.
排除标准
- •Fracture older than 2 weeks.
- •More than 25° of sagittal plane and/or 10° lateral angulation after reposition.
- •Intra-articular step >1mm.
- •Associated fractures in other bones (i e metacarpals, middle and distal phalanges) and/or tendon and nerve injuries in any finger.
- •Open fractures.
- •Patient age <18 years.
- •Inability to co-operate with the follow-up protocol (i.e. language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
研究组 & 干预措施
Conservative treatment
Fracture treated with closed reduction, custom made orthosis and early mobilization.
干预措施: Conservative treatment (Procedure)
Surgery
Fractures treated with closed reduction, percutaneous pinning (k-wires) and plaster.
干预措施: Percutaneous pinning (Procedure)
结局指标
主要结局
TAM (Total active range of motion)
时间窗: 3 years
Total active range of motion measured in degrees of the affected finger.
次要结局
- Patient related outcome measure DASH(3, 6 months and 1 and 3 years)
- Patient related outcome measure EQ-5D(3, 6 months and 1 and 3 years)
- Patient related outcome measure HQ-8(3, 6 months and 1 and 3 years)
- Grips strength(3, 6 months and 1 and 3 years)
- Patient related outcome measure HADS(3, 6 months and 1 and 3 years)
- Number of sick days(3 months)
研究者
Maria Wilcke
MD, Phd, Associate prof
Karolinska Institutet