Volar Locked Plating Versus Bridging External Fixation
This trial is active, not recruiting.
|Condition||distal radius fracture|
|Sponsor||University Hospital, Akershus|
|Collaborator||University of Oslo|
|Start date||September 2009|
|End date||December 2015|
|Trial size||140 participants|
|Trial identifier||NCT01062997, S-09101a 2009/2172|
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.
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.
|Observational model||case control|
time frame: 2 year follow-up
Male or female participants from 18 years up to 70 years old.
- 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.
- Gustillo-Anderson type III open fractures
- Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
- 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
|Official title||Volar Locked Plating Versus Bridging External Fixation|
|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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