Volar Locked Plating Versus Bridging External Fixation

NCT ID: NCT01062997

Last Updated: 2016-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Distal Radius Fracture

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Ola-Lars Hammer

PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akershus University Hospital

Sykehusveien 25, Nordbyhagen, Lorenskog, Norway

Site Status

Countries

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Norway

Other Identifiers

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S-09101a 2009/2172

Identifier Type: -

Identifier Source: org_study_id

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