Subcapital and Shaft Fractures of the 5. Metacarpal

NCT ID: NCT01242982

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

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

Conditions

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Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operation

Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires.

Group Type EXPERIMENTAL

Closed reduction and fixation with 2 pins

Intervention Type PROCEDURE

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

Conservative treatment

Treated conservatively with reduction and then Plaster of Paris.

Group Type ACTIVE_COMPARATOR

Reduction and Plaster of Paris

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivar Rossvoll, dr. med.

Role: STUDY_DIRECTOR

St. Olavs Hospital, orthopedic department

Locations

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Ålesund sjukehus, Helse Sunmøre

Ålesund, Møre og Romsdal, Norway

Site Status

Kristiansund sykehus, Helse Nord Møre og Romsdal

Kristiansund-N, Møre og Romsdal, Norway

Site Status

Molde sykehus, Helse Nordmøre og Romsdal

Molde, Møre og Romsdal, Norway

Site Status

Sykehuset Namsos, Helse Nord-Trøndelag

Namsos, Nord -Trøndelag, Norway

Site Status

Sykehuset i Vestfold-Tønsberg

Tønsberg, , Norway

Site Status

Countries

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Norway

Other Identifiers

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TOSL-2010

Identifier Type: -

Identifier Source: org_study_id

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