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

August 6, 2018 updated by: Thierry Christen, Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1005
        • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Syndactyly without compression
Relative immobilization with a syndactyly (CE conformity), no compression is worn.
Device: Syndactyly without compression
three week relative immobilization by syndactyly
Experimental: Syndactyly with compression
Relative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger
Device: Syndactyly with compression
three week relative immobilization by syndactyly and compression
Experimental: Rigid splint without compression
Rigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn
Device: Rigid splint without compression
three week rigid immobilization by splint
Experimental: Rigid splint with compression
Rigid immobilization with a custom made thermoplastic splint (CE conformity), compression (CE conformity) is worn over the finger
Device: Rigid splint with compression
three week rigid immobilization by splint and compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks, 6 weeks, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks, 6 weeks, 3 months, 6 months
Global function
Time Frame: 3 months
Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.
3 months
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)
3 months
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.
six months
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)
3 weeks, 6 weeks, 3 months, 6 months
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)
3 weeks, 6 weeks, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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