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Lower Limb Fractures clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03091114 Active, not recruiting - Clinical trials for Lower Limb Fractures

Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

Start date: March 27, 2017
Phase:
Study type: Observational

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.