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TerminatedNCT02548260Updated Aug 7, 2018

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

An interventional study of Syndactyly without compression and Syndactyly with compression in Finger Injuries, sponsored by Centre Hospitalier Universitaire Vaudois. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-07.

Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Finger Injuries
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Syndactyly without compression

    Relative immobilization with a syndactyly (CE conformity), no compression is worn.

    Device: Syndactyly without compression

  • Experimental
    Syndactyly with compression

    Relative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger

    Device: Syndactyly with 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

  • 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

Interventions

  • DeviceSyndactyly without compression

    three week relative immobilization by syndactyly

  • DeviceSyndactyly with compression

    three week relative immobilization by syndactyly and compression

  • DeviceRigid splint without compression

    three week rigid immobilization by splint

  • DeviceRigid splint with compression

    three week rigid immobilization by splint and compression

05

What researchers measure

Primary outcomes

  1. Change in digital mobility of wounded finger

    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.

    Time frame: 3 weeks, 6 weeks, 3 months, 6 months

Secondary outcomes

  1. Change in pain

    Patient has to rate the pain in the wounded finger during the last two days using a visual analog scale.

    Time frame: 3 weeks, 6 weeks, 3 months, 6 months

  2. Global function

    Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.

    Time frame: 3 months

  3. Satisfaction

    Patient has to rate its satisfaction with the treatment outcome on a scale from 1 to 10 (greatest satisfaction = 10)

    Time frame: 3 months

  4. Cost

    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.

    Time frame: six months

  5. Change in strength

    Pinch strength and global hand strength will be evaluated with specific devices (pinch and dynamometer)

    Time frame: 3 weeks, 6 weeks, 3 months, 6 months

  6. Change in finger diameter

    Diameter of the injured finger at the proximal interphalangeal joint will be assessed with a specific device (rings of various diameter)

    Time frame: 3 weeks, 6 weeks, 3 months, 6 months

06

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, Vaud 1005, Switzerland
07

Registry details

Key details

Study ID
NCT02548260
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Responsible party
Thierry Christen (Staff physician, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Sep 14, 2015
Start date
Mar 2016
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Aug 7, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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