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

NCT01139528 | Completed

• 1 other identifier: FASUUS 1529
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures of the Neck

Keywords

Fracture; 5th metacarpal bone; Bouquet pinning; Fractures of the neck of the 5th metacarpal bone

Outcome Measures

Primary Outcomes (1)

• Quick-DASH

  Validated hand function score

  6 weeks, 3 months, 1 year, 2 years

Secondary Outcomes (8)

• Patient satisfaction

  6 weeks, 3 months, 1 year, 2 years

• Pain

  1 week, 6 weeks, 3 months, 1 year, 2 years

• Eq-5d

  6 weeks, 3 months, 1 year, 2 years

• Complications

  1 week, 6 weeks, 3 months, 1 year, 2 years

• Sick-leave

  1 week, 6 weeks, 3 months (1 year, 2 years)

Study Arms (2)

Operative treatment

ACTIVE COMPARATOR

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

Conservative treatment

NO INTERVENTION

No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping

Interventions

Bouquet pinning of the 5th metacarpal bone PROCEDURE

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

Operative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator
• Asker & Baerum Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, NO-0407, Norway

Location

Related Publications (1)

• 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.

  PMID: 23060463 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Lars Nordsletten, Prof. MD, PhD

  University of Oslo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant orthopaedic surgeon

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: June 8, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

NO (1)