Volar Locked Plating Versus Bridging External Fixation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Oslo
Haukeland University Hospital
Information provided by (Responsible Party):
Ola-Lars Hammer, Akershus University College
ClinicalTrials.gov Identifier:
NCT01062997
First received: February 4, 2010
Last updated: March 21, 2014
Last verified: March 2014
  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:


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: February 2015
Estimated Primary Completion Date: February 2015 (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
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: NCT01062997

Locations
Norway
Akershus University Hospital
Sykehusveien 25, Nordbyhagen, Lorenskog, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
University of Oslo
Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Ola-Lars Hammer, PhD-student, Akershus University College
ClinicalTrials.gov Identifier: NCT01062997     History of Changes
Other Study ID Numbers: S-09101a 2009/2172
Study First Received: February 4, 2010
Last Updated: March 21, 2014
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 September 22, 2014