NCT02547181

Brief Summary

This Study is being done because the investigators would like to know if pain and hand function after having a boxer's fracture differs between being treated with supportive splinting or without splinting, but with behavioral modifications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

March 6, 2015

Last Update Submit

October 21, 2016

Conditions

Keywords

FractureFollow-upmetacarpal

Outcome Measures

Primary Outcomes (3)

  • hand function

    measured by Brief Michigan Hand Questionnaire (MHQ)

    4 weeks

  • hand function

    measured by Brief Michigan Hand Questionnaire (MHQ)

    8 weeks

  • hand function

    measured by Brief Michigan Hand Questionnaire (MHQ)

    12 weeks

Secondary Outcomes (3)

  • Grip strength

    4 weeks

  • Grip strength

    8 weeks

  • Grip strength

    12 weeks

Study Arms (2)

Splint

EXPERIMENTAL

Patients will be provided instructed to use a tensor bandage as well as specific behaviours to prevent movement of the injured part of the hand.

Behavioral: Splint

Behavioral Modification

EXPERIMENTAL

Patients are given a removable plaster/fiberglass splint with a tensor bandage underneath

Behavioral: Behavioral Modification

Interventions

Patient will be provided with tensor bandage and instructed on specific behaviors to prevent movement of the injured part of the hand.

Behavioral Modification
SplintBEHAVIORAL

fibreglass splint

Splint

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of true boxer's fracture
  • Candidate for either supportive splinting or tensor bandage
  • Speaking, read and write English

You may not qualify if:

  • Prior surgical treatment for boxer's fractures or other hand conditions.
  • Concurrent hand/wrist injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Interventions

Behavior TherapySplints

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesExternal FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Central Study Contacts

Catherine McMillan, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

September 11, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

October 24, 2016

Record last verified: 2016-10

Locations