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Subcapital and Shaft Fractures of the 5. Metacarpal

Primary Purpose

Fracture

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Closed reduction and fixation with 2 pins
Reduction and Plaster of Paris
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture focused on measuring 5. metacarpal fracture/fractures, subcapital, shaft, closed

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • voluntarily, only isolated subcapital og shaft fracture of the 5. metacarpal,operated/reduction within 10 days of injury,not intoxicated,degree of fracture dislocation minimum 30 degrees measured on the X-ray.

Exclusion Criteria:

  • open fractures, fractures of the head of 5. metacarpal/intraarticular fractures, patients who wants to be followed up at Hospitals outside the study area, earlier injury of the hand that might have influence on function.

Sites / Locations

  • Kristiansund sykehus, Helse Nord Møre og Romsdal
  • Molde sykehus, Helse Nordmøre og Romsdal
  • Ålesund sjukehus, Helse Sunmøre
  • Sykehuset Namsos, Helse Nord-Trøndelag
  • Sykehuset i Vestfold-Tønsberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Operation

Conservative treatment

Arm Description

Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires.

Treated conservatively with reduction and then Plaster of Paris.

Outcomes

Primary Outcome Measures

Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
The goal is 200 patients with shaft and subcapital fractures of the 5.metacarpal. In each group the goal is 100 patients there 50 patients will be operated (2 intramedullary pins) and 50 patients undergo conservative treatment. The follow up is 1 year.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2010
Last Updated
April 7, 2015
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01242982
Brief Title
Subcapital and Shaft Fractures of the 5. Metacarpal
Official Title
Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
problems to include patients, patients not showing up at check-up
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to find out the best treatment for subcapital and shaft fractures of the 5. metacarpal. It is a prospective randomized multicenter study. Comparing only fractures dislocated more than 30 degrees. One group will be operated with intramedullary pins and one group will be treated conservatively with reduction and then Plaster of Paris for 3 weeks. All patients will be followed up after 3, 6 and 12 months.
Detailed Description
See above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture
Keywords
5. metacarpal fracture/fractures, subcapital, shaft, closed

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Operation
Arm Type
Experimental
Arm Description
Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires.
Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
Treated conservatively with reduction and then Plaster of Paris.
Intervention Type
Procedure
Intervention Name(s)
Closed reduction and fixation with 2 pins
Intervention Description
Closed reduction and fixation with 2 antegrade intramedullary Kirschner wires. Cast for 2 weeks. Control after 2 and 5 weeks. Thereafter a control after 3,6 and 12 months
Intervention Type
Procedure
Intervention Name(s)
Reduction and Plaster of Paris
Intervention Description
Closed reduction in local anesthesia and a Plaster of Paris for max. 3 weeks. Control after 1 and 3 weeks, thereafter control after 3,6 and 12 months
Primary Outcome Measure Information:
Title
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
Description
The goal is 200 patients with shaft and subcapital fractures of the 5.metacarpal. In each group the goal is 100 patients there 50 patients will be operated (2 intramedullary pins) and 50 patients undergo conservative treatment. The follow up is 1 year.
Time Frame
2 -3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: voluntarily, only isolated subcapital og shaft fracture of the 5. metacarpal,operated/reduction within 10 days of injury,not intoxicated,degree of fracture dislocation minimum 30 degrees measured on the X-ray. Exclusion Criteria: open fractures, fractures of the head of 5. metacarpal/intraarticular fractures, patients who wants to be followed up at Hospitals outside the study area, earlier injury of the hand that might have influence on function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivar Rossvoll, dr. med.
Organizational Affiliation
St. Olavs Hospital, orthopedic department
Official's Role
Study Director
Facility Information:
Facility Name
Kristiansund sykehus, Helse Nord Møre og Romsdal
City
Kristiansund-N
State/Province
Møre og Romsdal
ZIP/Postal Code
6508
Country
Norway
Facility Name
Molde sykehus, Helse Nordmøre og Romsdal
City
Molde
State/Province
Møre og Romsdal
ZIP/Postal Code
6412
Country
Norway
Facility Name
Ålesund sjukehus, Helse Sunmøre
City
Ålesund
State/Province
Møre og Romsdal
ZIP/Postal Code
6026
Country
Norway
Facility Name
Sykehuset Namsos, Helse Nord-Trøndelag
City
Namsos
State/Province
Nord -Trøndelag
ZIP/Postal Code
7801
Country
Norway
Facility Name
Sykehuset i Vestfold-Tønsberg
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway

12. IPD Sharing Statement

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Subcapital and Shaft Fractures of the 5. Metacarpal

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