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Clinical Trials/NCT02548260
NCT02548260
Terminated
Not Applicable

Treatment of Proximal Interphalangeal Joint Injuries. Comparative Study of the Clinical Efficiency and Cost of Syndactyly Treatment Versus Immobilization and Compression Versus no Compression

Centre Hospitalier Universitaire Vaudois1 site in 1 country33 target enrollmentMarch 2016
ConditionsFinger Injuries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Finger Injuries
Sponsor
Centre Hospitalier Universitaire Vaudois
Enrollment
33
Locations
1
Primary Endpoint
Change in digital mobility of wounded finger
Status
Terminated
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
March 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thierry Christen

Staff physician

Centre Hospitalier Universitaire Vaudois

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

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)

Study Sites (1)

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