Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone (MC-studien)

April 23, 2015 updated by: Ida Neergård Sletten, Oslo University Hospital

Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial

A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, NO-0407
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone

Exclusion Criteria:

  • Less than 30 degrees of volar angulation in the fracture
  • rotational deformity
  • pseudoclawing
  • intra-articular involvement
  • ad latus displacement more than one half of a bone width
  • concomitant fractures or soft tissue damage
  • admittance more than 14 days after injury
  • non-compliant patient (language, drugs, tourist)
  • patient who refuses to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Operative treatment
Closed reduction of the fracture and osteosynthesis with 2-3 intramedullary K-wires (Bouquet method), cast treatment for 7-10 days followed by 5 weeks of buddy-strapping before removal of the K-pins
Procedure: Bouquet pinning of the 5th metacarpal bone
The fracture is reduced under general anesthesia and 2-3 K-pins are introduced in the medullar cavity to keep the fracture in the reduced position
No Intervention: Conservative treatment
No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick-DASH
Time Frame: 6 weeks, 3 months, 1 year, 2 years
Validated hand function score
6 weeks, 3 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 6 weeks, 3 months, 1 year, 2 years
VAS scale
6 weeks, 3 months, 1 year, 2 years
Pain
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
VAS scale
1 week, 6 weeks, 3 months, 1 year, 2 years
Eq-5d
Time Frame: 6 weeks, 3 months, 1 year, 2 years
Validated quality of life score
6 weeks, 3 months, 1 year, 2 years
Complications
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
All complications are noted
1 week, 6 weeks, 3 months, 1 year, 2 years
Sick-leave
Time Frame: 1 week, 6 weeks, 3 months (1 year, 2 years)
Days of sick-leave off work
1 week, 6 weeks, 3 months (1 year, 2 years)
Range of motion in the joints in the 5th finger measured by hand therapist
Time Frame: 3 months, 1 year, 2 years
total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
3 months, 1 year, 2 years
Grip strength
Time Frame: 3 months, 1 year, 2 years
Compared to the non-injured hand
3 months, 1 year, 2 years
Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand
Time Frame: 6 weeks, 1 year
6 weeks, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Asker & Baerum Hospital
University Hospital, Akershus

Investigators

  • Study Chair: Lars Nordsletten, Prof. MD, PhD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASUUS 1529

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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