Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression
Primary Purpose
Finger Injuries
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Syndactyly without compression
Syndactyly with compression
Rigid splint without compression
Rigid splint with compression
Sponsored by
About this trial
This is an interventional treatment trial for Finger Injuries
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
Sites / Locations
- Centre Hospitalier Universitaire Vaudois
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Syndactyly without compression
Syndactyly with compression
Rigid splint without compression
Rigid splint with compression
Arm Description
Relative immobilization with a syndactyly (CE conformity), no compression is worn.
Relative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger
Rigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn
Rigid immobilization with a custom made thermoplastic splint (CE conformity), compression (CE conformity) is worn over the finger
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in pain
Patient has to rate the pain in the wounded finger during the last two days using a visual analog scale.
Global function
Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.
Satisfaction
Patient has to rate its satisfaction with the treatment outcome on a scale from 1 to 10 (greatest satisfaction = 10)
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.
Change in strength
Pinch strength and global hand strength will be evaluated with specific devices (pinch and dynamometer)
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)
Full Information
NCT ID
NCT02548260
First Posted
September 3, 2015
Last Updated
August 6, 2018
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT02548260
Brief Title
Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Finger Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Syndactyly without compression
Arm Type
Experimental
Arm Description
Relative immobilization with a syndactyly (CE conformity), no compression is worn.
Arm Title
Syndactyly with compression
Arm Type
Experimental
Arm Description
Relative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger
Arm Title
Rigid splint without compression
Arm Type
Experimental
Arm Description
Rigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn
Arm Title
Rigid splint with compression
Arm Type
Experimental
Arm Description
Rigid immobilization with a custom made thermoplastic splint (CE conformity), compression (CE conformity) is worn over the finger
Intervention Type
Device
Intervention Name(s)
Syndactyly without compression
Intervention Description
three week relative immobilization by syndactyly
Intervention Type
Device
Intervention Name(s)
Syndactyly with compression
Intervention Description
three week relative immobilization by syndactyly and compression
Intervention Type
Device
Intervention Name(s)
Rigid splint without compression
Intervention Description
three week rigid immobilization by splint
Intervention Type
Device
Intervention Name(s)
Rigid splint with compression
Intervention Description
three week rigid immobilization by splint and compression
Primary Outcome Measure Information:
Title
Change in digital mobility of wounded finger
Description
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 Outcome Measure Information:
Title
Change in pain
Description
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
Title
Global function
Description
Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.
Time Frame
3 months
Title
Satisfaction
Description
Patient has to rate its satisfaction with the treatment outcome on a scale from 1 to 10 (greatest satisfaction = 10)
Time Frame
3 months
Title
Cost
Description
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
Title
Change in strength
Description
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
Title
Change in finger diameter
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1005
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression
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