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Subcapital and Shaft Fractures of the 5. Metacarpal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01242982
Recruitment Status : Terminated (problems to include patients, patients not showing up at check-up)
First Posted : November 17, 2010
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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.


Condition or disease Intervention/treatment
Fracture Procedure: Closed reduction and fixation with 2 pins Procedure: Reduction and Plaster of Paris

Detailed Description:
See above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation
Study Start Date : January 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242982


Locations
Norway
Kristiansund sykehus, Helse Nord Møre og Romsdal
Kristiansund-N, Møre og Romsdal, Norway, 6508
Molde sykehus, Helse Nordmøre og Romsdal
Molde, Møre og Romsdal, Norway, 6412
Ålesund sjukehus, Helse Sunmøre
Ålesund, Møre og Romsdal, Norway, 6026
Sykehuset Namsos, Helse Nord-Trøndelag
Namsos, Nord -Trøndelag, Norway, 7801
Sykehuset i Vestfold-Tønsberg
Tønsberg, Norway, 3103
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Study Director: Ivar Rossvoll, dr. med. St. Olavs Hospital, orthopedic department

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01242982     History of Changes
Other Study ID Numbers: TOSL-2010
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by St. Olavs Hospital:
5. metacarpal fracture/fractures
subcapital
shaft
closed

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries