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
|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|
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 (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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)
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
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Vaud, Switzerland, 1005|