Subcapital and Shaft Fractures of the 5. Metacarpal

Study Overview
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Brief Summary
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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
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See above

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

Conditions
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Fracture

Intervention / Treatment
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* Procedure: Closed reduction and fixation with 2 pins
* Procedure: Reduction and Plaster of Paris


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shaft, 5. metacarpal fracture/fractures, subcapital, closed