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Clinical Trials/NCT01242982
NCT01242982
Terminated
Not Applicable

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

St. Olavs Hospital5 sites in 1 country39 target enrollmentJanuary 2011
ConditionsFracture

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture
Sponsor
St. Olavs Hospital
Enrollment
39
Locations
5
Primary Endpoint
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
Status
Terminated
Last Updated
11 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
May 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • voluntarily, only isolated subcapital og shaft fracture of the
  • 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
  • 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.

Outcomes

Primary Outcomes

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.

Study Sites (5)

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