Volar Locked Plating Versus Bridging External Fixation

University Hospital, Akershus

Status: Completed

Conditions: Distal Radius Fracture

Study type: Observational

Funder types: Other

Identifiers

NCT01062997

S-09101a 2009/2172

Details and patient eligibility

About

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.

Full 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).

Enrollment: 166 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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