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

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ClinicalTrials.gov Identifier: NCT02548260
Recruitment Status : Terminated
First Posted : September 14, 2015
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Thierry Christen, Centre Hospitalier Universitaire Vaudois

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.

Condition or disease Intervention/treatment Phase
Finger Injuries Device: Syndactyly without compression Device: Syndactyly with compression Device: Rigid splint without compression Device: Rigid splint with compression Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Global function [ Time Frame: 3 months ]
    Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.

  3. 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)

  4. 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.

  5. 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)

  6. 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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548260


Locations
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Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1005
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
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Responsible Party: Thierry Christen, Staff physician, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02548260    
Other Study ID Numbers: 301/15
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Syndactyly
Wounds and Injuries
Finger Injuries
Hand Injuries
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities