Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

Study Overview
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Brief Summary
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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.

Detailed Description
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see study protocol: https://uni-wh.de/fileadmin/user_upload/03_G/07_Humanmedizin/05_Institute/IFOM/IFF-PROFAK_Protocol.pdf

Official Title
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Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures: a Prospective Cohort Study

Conditions
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Lower Limb Fractures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (≥18 years) with isolated fractures scheduled for urgent or semi-urgent surgery using internal fixations because of the following lower limb fractures will be included: Tibia fractures Femur fractures Ankle fractures Calcaneal fractures Exclusion Criteria: Periprosthetic fractures Insufficient knowledge of the German language Strong cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of internal fixation | Failure of internal fixation due to nonunion or implant failure | 6 months +/- 2 weeks (survival analysis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain numerical rating scale (NRS) >3 | 6 months +/- 2 weeks | 
| Physical functioning | E.g. climbing stairs | 6 months +/- 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractures, risk prediction