Volar Locked Plating Versus Bridging External Fixation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Distal Radius Fracture
- Sponsor
- University Hospital, Akershus
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- Quick-DASH
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Investigators
Ola-Lars Hammer
PhD-student
University Hospital, Akershus
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Quick-DASH
Time Frame: 2 year follow-up