Treatment of Proximal Interphalangeal Joint Injuries. Comparative Study of the Clinical Efficiency and Cost of Syndactyly Treatment Versus Immobilization and Compression Versus no Compression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Change in digital mobility of wounded finger
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Syndactyly without compression
Relative immobilization with a syndactyly (CE conformity), no compression is worn.
Intervention: Syndactyly without compression (Device)
Syndactyly with compression
Relative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger
Intervention: Syndactyly with compression (Device)
Rigid splint without compression
Rigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn
Intervention: 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
Intervention: Rigid splint with compression (Device)
Outcomes
Primary Outcomes
Change in digital mobility of wounded finger
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Thierry Christen
Staff physician
Centre Hospitalier Universitaire Vaudois