NCT02548260

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

September 3, 2015

Last Update Submit

August 6, 2018

Conditions

Finger Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in pain

    3 weeks, 6 weeks, 3 months, 6 months

  • Global function

    3 months

  • Satisfaction

    3 months

  • Cost

    six months

  • Change in strength

    3 weeks, 6 weeks, 3 months, 6 months

  • +1 more secondary outcomes

Study Arms (4)

Syndactyly without compression

EXPERIMENTAL

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

Device: Syndactyly without compression

Syndactyly with compression

EXPERIMENTAL

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

Device: Syndactyly with compression

Rigid splint without compression

EXPERIMENTAL

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

Device: Rigid splint without compression

Rigid splint with compression

EXPERIMENTAL

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

Device: Rigid splint with compression

Interventions

Syndactyly without compressionDEVICE

three week relative immobilization by syndactyly

Syndactyly without compression
Syndactyly with compressionDEVICE

three week relative immobilization by syndactyly and compression

Syndactyly with compression
Rigid splint without compressionDEVICE

three week rigid immobilization by splint

Rigid splint without compression
Rigid splint with compressionDEVICE

three week rigid immobilization by splint and compression

Rigid splint with compression

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

Location

MeSH Terms

Conditions

Finger Injuries

Condition Hierarchy (Ancestors)

Hand InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff physician

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 14, 2015

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

CH(1)