Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

• Conditions: Lower Limb Fractures

• Registration Number: NCT03091114
• Lead Sponsor: University of Witten/Herdecke

Brief 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

Study Timeline

• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-20
• Study Start: 2017-03-27
• Study First Posted: 2017-03-27
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-05
• Last Update Posted: 2018-10-09
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

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Exclusion Criteria

• Periprosthetic fractures
• Insufficient knowledge of the German language
• Strong cognitive impairment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure of internal fixation	6 months +/- 2 weeks (survival analysis)	Failure of internal fixation due to nonunion or implant failure

Secondary Outcome Measures

Name	Time	Method
Pain	6 months +/- 2 weeks	Pain numerical rating scale (NRS) \>3
Physical functioning	6 months +/- 2 weeks	E.g. climbing stairs

Trial Locations

Locations (1)

Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim; 🇩🇪 Cologne, North-Rhine-Westfalia, Germany