Subcapital and Shaft Fractures of the 5. Metacarpal

April 7, 2015 updated by: St. Olavs Hospital

Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

See above

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tønsberg, Norway, 3103
        • Sykehuset i Vestfold-Tønsberg
    • Møre og Romsdal
      • Kristiansund-N, Møre og Romsdal, Norway, 6508
        • Kristiansund sykehus, Helse Nord Møre og Romsdal
      • Molde, Møre og Romsdal, Norway, 6412
        • Molde sykehus, Helse Nordmøre og Romsdal
      • Ålesund, Møre og Romsdal, Norway, 6026
        • Ålesund sjukehus, Helse Sunmøre
    • Nord -Trøndelag
      • Namsos, Nord -Trøndelag, Norway, 7801
        • Sykehuset Namsos, Helse Nord-Trøndelag

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Operation
Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires.
Procedure: Closed reduction and fixation with 2 pins
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
Active Comparator: Conservative treatment
Treated conservatively with reduction and then Plaster of Paris.
Procedure: Reduction and Plaster of Paris
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
Time Frame: 2 -3 years
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.
2 -3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Study Director: Ivar Rossvoll, dr. med., St. Olavs Hospital, orthopedic department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria

November 16, 2010

First Posted (Estimate)

November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOSL-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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