Lower Limb Fractures Clinical Trial
Official title:
Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures: a Prospective Cohort Study
Background:
A predictive factor is a measure that predicts treatment response. Decisions on internal
fixations of lower limb fractures should regard predictive factors to personalize (e.g. age)
treatment. However for most potentially influencing factors valid data on the predictive
value is sparse.
Objectives:
The objective of this study is to identify predictive factors and quantify their predictive
ability for treatment failure in patients with limb fractures treated with osteosynthesis.
Methods:
Patients Adult patients (≥18 year) with isolated fractures scheduled for urgent or
semi-urgent surgery using internal fixations because of lower limb fractures.
The predictive value of the following exposures will be analyzed:
- Age
- Gender
- Diabetes
- Smoking status
- Body Mass Index
- Open fractures
- Peripheral arterial disease
Outcome The outcome will be (time to) reoperation of the same fracture because of failure of
internal fixation due to nonunion or implant failure.
Study design A prospective observational cohort study will be performed. Sample size 300
patients will be included.
Statistical analysis:
For the main analysis a multivariate stratified Cox proportional hazard model will be used.
The Model will be stratified according to the indication. In the Cox proportional hazard
model all predictive factors will be entered simultaneously to quantify the independent
influence (adjusted for all other factors) of each factor. The strength of prediction will be
described with hazard rations and their corresponding 95% confidence intervals.
see study protocol: https://uni-wh.de/fileadmin/user_upload/03_G/07_Humanmedizin/05_Institute/IFOM/IFF-PROFAK_Pro tocol.pdf ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02742376 -
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N/A |