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

Oslo University Hospital1 site in 1 country85 target enrollmentMay 2010

ConditionsFractures of the Neck

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fractures of the Neck
Sponsor: Oslo University Hospital
Enrollment: 85
Locations: 1
Primary Endpoint: Quick-DASH
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

October 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oslo University Hospital

Responsible Party

Principal Investigator

Ida Neergård Sletten

Consultant orthopaedic surgeon

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quick-DASH

Time Frame: 6 weeks, 3 months, 1 year, 2 years

Validated hand function score

Secondary Outcomes

Grip strength(3 months, 1 year, 2 years)
Complications(1 week, 6 weeks, 3 months, 1 year, 2 years)
Patient satisfaction(6 weeks, 3 months, 1 year, 2 years)
Eq-5d(6 weeks, 3 months, 1 year, 2 years)
Range of motion in the joints in the 5th finger measured by hand therapist(3 months, 1 year, 2 years)
Pain(1 week, 6 weeks, 3 months, 1 year, 2 years)
Sick-leave(1 week, 6 weeks, 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(6 weeks, 1 year)