NCT03091114

Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: University of Witten/Herdecke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

see study protocol: https://uni-wh.de/fileadmin/user\_upload/03\_G/07\_Humanmedizin/05\_Institute/IFOM/IFF-PROFAK\_Protocol.pdf

Conditions

• Lower Limb Fractures

Timeline

• Start date: 2017-03-27
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-03-27
• Last updated: 2018-10-09

Locations

1 site across 1 country: Germany