Clinical trial NCT02548260: Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression
Official title: Treatment of Proximal Interphalangeal Joint Injuries. Comparative Study of the Clinical Efficiency and Cost of Syndactyly Treatment Versus Immobilization and Compression Versus no Compression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Finger Injuries
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in digital mobility of wounded finger
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months
Secondary outcomes:
measure: Change in pain
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months
measure: Global function
timeFrame: 3 months
measure: Satisfaction
timeFrame: 3 months
measure: Cost
timeFrame: six months
measure: Change in strength
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months
measure: Change in finger diameter
timeFrame: 3 weeks, 6 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
References: