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Subcapital and Shaft Fractures of the 5. Metacarpal

This study has been terminated.
(problems to include patients, patients not showing up at check-up)
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01242982
First received: November 16, 2010
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Fracture
 Procedure: Closed reduction and fixation with 2 pins
Procedure: Reduction and Plaster of Paris

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal [ Time Frame: 2 -3 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 39
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01242982     History of Changes
Other Study ID Numbers: TOSL-2010
Study First Received: November 16, 2010
Last Updated: June 13, 2012
Health Authority: Norway: Ethics Committee

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013