Volar Locked Plating Versus Bridging External Fixation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01062997

Enrollment

166

Registered

2010-02-05

Start date

2009-09-30

Completion date

2016-04-30

Last updated

2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Brief 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.

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Quick-DASH	2 year follow-up

Countries

Norway

Outcome results