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

Finger Injuries Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02548260
• Other study ID #: 301/15
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Finger Injuries
• Syndactyly
• Wounds and Injuries

Intervention

Device:
• Syndactyly without compression
three week relative immobilization by syndactyly
• Syndactyly with compression
three week relative immobilization by syndactyly and compression
• Rigid splint without compression
three week rigid immobilization by splint
• Rigid splint with compression
three week rigid immobilization by splint and compression

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks, 6 weeks, 3 months, 6 months
Secondary	Change in pain	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
Secondary	Global function	Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.	3 months
Secondary	Satisfaction	Patient has to rate its satisfaction with the treatment outcome on a scale from 1 to 10 (greatest satisfaction = 10)	3 months
Secondary	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.	six months
Secondary	Change in strength	Pinch strength and global hand strength will be evaluated with specific devices (pinch and dynamometer)	3 weeks, 6 weeks, 3 months, 6 months
Secondary	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)	3 weeks, 6 weeks, 3 months, 6 months