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

NCT ID: NCT02548260

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Finger Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Syndactyly without compression

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

Group Type EXPERIMENTAL

Syndactyly without compression

Intervention Type DEVICE

three week relative immobilization by syndactyly

Syndactyly with compression

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

Group Type EXPERIMENTAL

Syndactyly with compression

Intervention Type DEVICE

three week relative immobilization by syndactyly and compression

Rigid splint without compression

Rigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn

Group Type EXPERIMENTAL

Rigid splint without compression

Intervention Type DEVICE

three week rigid immobilization by splint

Rigid splint with compression

Rigid immobilization with a custom made thermoplastic splint (CE conformity), compression (CE conformity) is worn over the finger

Group Type EXPERIMENTAL

Rigid splint with compression

Intervention Type DEVICE

three week rigid immobilization by splint and compression

Interventions

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Syndactyly without compression

three week relative immobilization by syndactyly

Intervention Type DEVICE

Syndactyly with compression

three week relative immobilization by syndactyly and compression

Intervention Type DEVICE

Rigid splint without compression

three week rigid immobilization by splint

Intervention Type DEVICE

Rigid splint with compression

three week rigid immobilization by splint and compression

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Thierry Christen

Staff physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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301/15

Identifier Type: -

Identifier Source: org_study_id

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