Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone

Fractures of the Neck Clinical Trial

— MC-studien  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139528
• Other study ID #: FASUUS 1529
• Status: Completed
• Phase: N/A
• First received: May 18, 2010
• Last updated: April 23, 2015
• Start date: May 2010
• Est. completion date: October 2013

Study information

• Verified date: April 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures of the Neck
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Asker & Baerum Hospital, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick-DASH	Validated hand function score	6 weeks, 3 months, 1 year, 2 years	No
Secondary	Patient satisfaction	VAS scale	6 weeks, 3 months, 1 year, 2 years	No
Secondary	Pain	VAS scale	1 week, 6 weeks, 3 months, 1 year, 2 years	No
Secondary	Eq-5d	Validated quality of life score	6 weeks, 3 months, 1 year, 2 years	No
Secondary	Complications	All complications are noted	1 week, 6 weeks, 3 months, 1 year, 2 years	No
Secondary	Sick-leave	Days of sick-leave off work	1 week, 6 weeks, 3 months (1 year, 2 years)	No
Secondary	Range of motion in the joints in the 5th finger measured by hand therapist	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	No
Secondary	Grip strength	Compared to the non-injured hand	3 months, 1 year, 2 years	No
Secondary	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	No