Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-27

Study Completion Date

2018-12-31

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.

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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

Conditions

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Lower Limb Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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