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Volar Locked Plating Versus Bridging External Fixation

This study is currently recruiting participants.
Verified February 2010 by University Hospital, Akershus
Sponsor:
Collaborators:
University of Oslo
Haukeland University Hospital
Information provided by:
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01062997
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3.

Hypothesis:

There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.


Condition
Distal Radius Fracture

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Quick-DASH [ Time Frame: 2 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

We have designed a randomized, prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3. On the basis of power analysis a total of 140 patients are to be included in this project. The follow-up period is 2 years and evaluation is based on x-ray analysis, grip strength, range of movement, pain and various tools to measure quality of life and satisfaction with the treatment (EQ-5d, SF-36, Quick-DASH).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture

Criteria

Inclusion Criteria:

  • All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA).
  • All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion.

Exclusion Criteria:

  • Gustillo-Anderson type III open fractures
  • Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
  • Dementia
  • Congenital anomaly
  • Bilateral radius fracture
  • Pathological fracture other than osteoporotic fracture
  • Congenital bone disease (for example osteogenesis imperfecta)
  • Age below 18 and above 70
  • Disabling nury to other parts og the movement apparatus at the same time as the current injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062997

Locations
Norway
Akershus University Hospital Recruiting
Sykehusveien 25, Nordbyhagen, Lorenskog, Norway, 1478
Contact: Ola-Lars Hammer, MD     +47 94179767     oham@ahus.no    
Sponsors and Collaborators
University Hospital, Akershus
University of Oslo
Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Jan Erik Madsen, Ph.D., University of Oslo
ClinicalTrials.gov Identifier: NCT01062997     History of Changes
Other Study ID Numbers: S-09101a 2009/2172
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: The National Committees for Research Ethics: Norway

Additional relevant MeSH terms:
Radius Fractures
Forearm Injuries
Arm Injuries
Wounds and Injuries
Fractures, Bone

ClinicalTrials.gov processed this record on May 23, 2013