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Early Range of Motion in 5th Metacarpal Fracture

Primary Purpose

Fracture

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Early Active Range of Motion
Standard Immobilization
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture focused on measuring 5th metacarpal, EAROM, standard immobilization, Boxer's Fracture, hand function, DASH, trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age equal or greater than 18 years
  2. Fifth metacarpal neck fracture, 9 or fewer days since injury
  3. Equal or less than 40 degrees of dorsal fracture angulation on lateral x-ray. Angle is measured between the line along the longitudinal axis of the metacarpal shaft and the line from the centre of the metacarpal head to the fracture site.
  4. No angulation or malrotation
  5. No clinical fracture shortening (ie. Inability to extend fifth digit)
  6. Non-operative treatment
  7. Volar or ulnar gutter splint (MCP flexed, IPs extended)

Exclusion Criteria:

  1. Metabolic bone disease
  2. "Open fracture" with soft tissue loss overlying fracture site
  3. Tendon injury
  4. Neurovascular injury
  5. Clinical rotatory malalignment
  6. Fracture shortening demonstrated by "pseudoclawing"
  7. Other fracture in the ipsilateral upper extremity
  8. Any operative indication
  9. Previous fracture to the involved fifth ray

Sites / Locations

  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Active Range of Motion

Standard Immoblization

Arm Description

Early Active Range of Motion (EAROM) 3-9 days following hand fracture

Standard immobilization with plaster splint for 21-27 following hand fracture

Outcomes

Primary Outcome Measures

Hand function as measured by validated scoring - the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure

Secondary Outcome Measures

HR-QOL

Full Information

First Posted
May 1, 2015
Last Updated
December 11, 2017
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02441790
Brief Title
Early Range of Motion in 5th Metacarpal Fracture
Official Title
Early Range of Motion in 5th Metacarpal Fracture: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment Difficulty
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Fractures of the fifth metacarpal neck are the most common injury involving the upper extremity. Patients are typically young adult males. Restoring function quickly and reliably for return to work and/or activity is important; these patients are a significant labour force demographic. Treatment is historically splinting for approximately 3-4 weeks. Splinting a fracture is a "trade-off". Immobilization allows stabilization and fracture healing, but also causes hand stiffness and weakness leading to impaired function. Little prospective research exists; there is no agreement for ideal duration of splinting or therapy, demonstrating clinical equipoise. A new concept in hand rehabilitation is "early active range of motion" (EAROM). The objective of this trial is to establish if EAROM provides improved early (6 week) hand function when compared to standard immobilization.
Detailed Description
Fractures of the fifth metacarpal neck ("boxer's fractures"), are the most common injury to the upper extremity. They are the result of axial force on a flexed metacarpalphalangeal (MCP) joint. Typically, they are caused by striking a hard object with a closed fist, breaking the knuckle on the "little" finger. Restoring hand function quickly and reliably for return to work and/or activity is of utmost importance. These patients are a significant labour force demographic. Since the injury is not characteristically sustained at work, "return-to-work"is an important patient consideration for lost wages. Treatment for fractures of the fifth metacarpal neck is typically non-operative. In the absence of urgent operative indications (ie. "open fractures" or contamination), non-operative management is initiated. Closed reduction is performed with local anaesthesia and manual manipulation. A splint is then applied. Repeat x-rays are obtained to determine positioning. If anatomic alignment is stable, no surgery is indicated and the patient remains splinted for 3-4 weeks. "Early active range of motion" (EAROM) refers to actively moving the fractured digit once fracture callus has begun formation at 3 days. In practice, EAROM begins at 3-14 days.It involves controlled, active tendon glide exercises where the patient attempts to move joints in the injured hand. This motion is perpendicular to the fractures pattern, applying a compressive force to the fracture. From basic science models, compressive forces of EAROM improve rate of bone callus differentiation,early healing,fracture angulation and load bearing.This study aims to translate these basic science concepts to practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture
Keywords
5th metacarpal, EAROM, standard immobilization, Boxer's Fracture, hand function, DASH, trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Active Range of Motion
Arm Type
Experimental
Arm Description
Early Active Range of Motion (EAROM) 3-9 days following hand fracture
Arm Title
Standard Immoblization
Arm Type
Active Comparator
Arm Description
Standard immobilization with plaster splint for 21-27 following hand fracture
Intervention Type
Behavioral
Intervention Name(s)
Early Active Range of Motion
Intervention Description
3-9 days
Intervention Type
Behavioral
Intervention Name(s)
Standard Immobilization
Intervention Description
21-27 days
Primary Outcome Measure Information:
Title
Hand function as measured by validated scoring - the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
HR-QOL
Time Frame
3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age equal or greater than 18 years Fifth metacarpal neck fracture, 9 or fewer days since injury Equal or less than 40 degrees of dorsal fracture angulation on lateral x-ray. Angle is measured between the line along the longitudinal axis of the metacarpal shaft and the line from the centre of the metacarpal head to the fracture site. No angulation or malrotation No clinical fracture shortening (ie. Inability to extend fifth digit) Non-operative treatment Volar or ulnar gutter splint (MCP flexed, IPs extended) Exclusion Criteria: Metabolic bone disease "Open fracture" with soft tissue loss overlying fracture site Tendon injury Neurovascular injury Clinical rotatory malalignment Fracture shortening demonstrated by "pseudoclawing" Other fracture in the ipsilateral upper extremity Any operative indication Previous fracture to the involved fifth ray
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael James Cooper, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

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Early Range of Motion in 5th Metacarpal Fracture

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