Clinical Trial: Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Centre Hospitalier Universitaire Vaudois

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in pain [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months ]
    Patient has to rate the pain in the wounded finger during the last two days using a visual analog scale.
  • Global function [ Time Frame: 3 months ]
    Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.
  • Satisfaction [ Time Frame: 3 months ]
    Patient has to rate its satisfaction with the treatment outcome on a scale from 1 to 10 (greatest satisfaction = 10)
  • Cost [ Time Frame: six months ]
    The cost of the whole treatment will be calculated for each patient after the final consultation at 6 months. It will include the consultations themselves, the cost of the devices used, the hand therapy, the absence from work.
  • Change in strength [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months ]
    Pinch strength and global hand strength will be evaluated with specific devices (pinch and dynamometer)
  • Change in finger diameter [ Time Frame: 3 weeks, 6 weeks, 3 months, 6 months ]
    Diameter of the injured finger at the proximal interphalangeal joint will be assessed with a specific device (rings of various diameter)


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire Vaudois

Dates:
Date Received: September 3, 2015
Date Started: March 2016
Date Completion: March 2017
Last Updated: August 5, 2016
Last Verified: August 2016