Treatment of Proximal Interphalangeal Joint Injuries. Comparative Study of the Clinical Efficiency and Cost of Syndactyly Treatment Versus Immobilization and Compression Versus no Compression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in digital mobility of wounded finger
研究概览
简要总结
Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no treatment has been shown to be superior. The investigators wish to study the effectiveness of syndactyly versus digital splint when comparing joint mobility. The investigators also wish to study the effectiveness of finger compression in reducing edema and therefore allowing a greater arc of motion.
详细描述
Proximal interphalangeal joint (PIPJ) injuries of the fingers are a common occurrence. They may be treated various ways: strict immobilization in a finger splint for one to three weeks, syndactyly, no immobilization. Immobilization is often responsible for joint stiffness whereas immediate mobilization might produce pain.
Injuries to the joints of the hand produce edema that is responsible for additional stiffness. Compressive garment may be worn to limit the extent of the edema and help its resorption.
Although PIPJ injuries are frequent, their treatment does not benefit from a consensus. Most studies are retrospective or aimed at a pediatric population. The investigators wish to evaluate the outcome of PIPJ injury after different treatments: either strict immobilization in a rigid splint for three weeks, of relative immobilization in a syndactyly for three weeks.The investigators also wish to study the effect of finger compression on edema resolution and finger motion. Therefore there will be four treatment groups: syndactyly with and without compression, rigid splint with and without compression.
The study will be conducted in the hand surgery unit of a university hospital in a prospective way. The assignment to a particular treatment group will be randomly performed. Patients will be followed for 6 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •proximal interphalangeal joint injury with or without dorsal or lateral luxation
- •less than seven days after injury
- •injured joint stability
- •fracture of the palmar rim of the intermediate phalanx less than 30% of articular surface
排除标准
- •palmar luxation of the proximal interphalangeal joint
- •fracture of the palmar rim of the intermediate phalanx greater than 30% of articular surface
- •injury to the central band of the extensor tendon
- •fracture other than palmar rim of the intermediate phalanx less than 30% of articular surface
- •non reducible luxation
研究组 & 干预措施
Syndactyly without compression
Relative immobilization with a syndactyly (CE conformity), no compression is worn.
干预措施: Syndactyly without compression (Device)
Syndactyly with compression
Relative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger
干预措施: Syndactyly with compression (Device)
Rigid splint without compression
Rigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn
干预措施: Rigid splint without compression (Device)
Rigid splint with compression
Rigid immobilization with a custom made thermoplastic splint (CE conformity), compression (CE conformity) is worn over the finger
干预措施: Rigid splint with compression (Device)
结局指标
主要结局
Change in digital mobility of wounded finger
时间窗: 3 weeks, 6 weeks, 3 months, 6 months
Evaluation of digital mobility by measuring the palm-tip of the finger distance with a ruler. The active and passive mobility of the metacarpophalangeal, proximal and distal interphalangeal joints will be measured with a goniometer.
次要结局
- Cost(six months)
- Change in finger diameter(3 weeks, 6 weeks, 3 months, 6 months)
- Satisfaction(3 months)
- Change in strength(3 weeks, 6 weeks, 3 months, 6 months)
- Change in pain(3 weeks, 6 weeks, 3 months, 6 months)
- Global function(3 months)
研究者
Thierry Christen
Staff physician
Centre Hospitalier Universitaire Vaudois