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CompletedNCT01062997Updated Aug 9, 2016

Volar Locked Plating Versus Bridging External Fixation

An observational study in Distal Radius Fracture, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-09.

Sponsored by University Hospital, Akershus · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
166
Ages
18 Years to 70 Years
Sex
All
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Study summary

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.

Read the 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).

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Conditions studied

  • Distal Radius Fracture
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In context

Radius Fractures

272 studies on the registry are indexed under Radius Fractures; 35 are open to participants now.

This study's enrollment of 166 is above the median of 60 across 45 observational studies indexed under Radius Fractures.

Browse Radius Fractures studies →

Lead sponsor

University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
166 participants (actual)
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What researchers measure

Primary outcomes

  1. Quick-DASH

    Time frame: 2 year follow-up

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Study locations

1 site
  • Akershus University Hospital
    Sykehusveien 25, Nordbyhagen, Lorenskog 1478, Norway
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01062997
Lead sponsor
University Hospital, Akershus
Collaborators
University of Oslo, Haukeland University Hospital
Responsible party
Ola-Lars Hammer (PhD-student, University Hospital, Akershus) — Principal investigator
First posted
Feb 5, 2010
Start date
Sep 2009
Primary completion
Dec 2015
Completion
Apr 2016
Last update
Aug 9, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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