Trials / Completed
CompletedNCT01062997
Volar Locked Plating Versus Bridging External Fixation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 166 (actual)
- Sponsor
- University Hospital, Akershus · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2015-12-01
- Completion
- 2016-04-01
- First posted
- 2010-02-05
- Last updated
- 2016-08-09
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT01062997. Inclusion in this directory is not an endorsement.