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

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: Fractures of the Neck
• Intervention / Treatment: Procedure: Bouquet pinning of the 5th metacarpal bone

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Validated hand function score	6 weeks, 3 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	VAS scale	6 weeks, 3 months, 1 year, 2 years
Pain	VAS scale	1 week, 6 weeks, 3 months, 1 year, 2 years
Eq-5d	Validated quality of life score	6 weeks, 3 months, 1 year, 2 years
Complications	All complications are noted	1 week, 6 weeks, 3 months, 1 year, 2 years
Sick-leave	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	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	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		6 weeks, 1 year

Collaborators and Investigators

• 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

General Publications

• Sletten IN, Nordsletten L, Hjorthaug GA, Hellund JC, Holme I, Kvernmo HD. Assessment of volar angulation and shortening in 5th metacarpal neck fractures: an inter- and intra-observer validity and reliability study. J Hand Surg Eur Vol. 2013 Jul;38(6):658-66. doi: 10.1177/1753193412461582. Epub 2012 Oct 11.

Study record dates

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: Fracture; 5th metacarpal bone; Bouquet pinning; Fractures of the neck of the 5th metacarpal bone
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: FASUUS 1529