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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital, Akershus
Asker & Baerum Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01139528
First received: May 18, 2010
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Fractures of the Neck
Procedure: Bouquet pinning of the 5th metacarpal bone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Quick-DASH [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    Validated hand function score


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    VAS scale

  • Pain [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    VAS scale

  • Eq-5d [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    Validated quality of life score

  • Complications [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    All complications are noted

  • Sick-leave [ Time Frame: 1 week, 6 weeks, 3 months (1 year, 2 years) ] [ Designated as safety issue: No ]
    Days of sick-leave off work

  • Range of motion in the joints in the 5th finger measured by hand therapist [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint

  • Grip strength [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
    Compared to the non-injured hand

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139528

Contacts
Contact: Ida Neergård Sletten, MD +4702770 ida.sletten@live.no
Contact: Hebe Desiree Kvernmo, MD, PhD +4702770 hebe.kvernmo@gmail.com

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, NO-0407
Contact: Ida Neergård Sletten, Cand.med.         
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Asker & Baerum Hospital
Investigators
Study Chair: Lars Nordsletten, Prof. MD, PhD University of Oslo, Norway
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ida Neergård Sletten, MD, Oslo University Hospital-Ullevaal
ClinicalTrials.gov Identifier: NCT01139528     History of Changes
Other Study ID Numbers: FASUUS 1529
Study First Received: May 18, 2010
Last Updated: April 18, 2011
Health Authority: Norway: Ethics Committee

Keywords provided by Oslo University Hospital:
Fracture
5th metacarpal bone
Bouquet pinning
Fractures of the neck of the 5th metacarpal bone

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014