Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

Lower Limb Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03091114
• Other study ID #: V01-A0
• Status: Active, not recruiting
• Start date: March 27, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2018
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Lower Limb Fractures

Locations

Country	Name	City	State
Germany	Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim	Cologne	North-Rhine-Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of internal fixation	Failure of internal fixation due to nonunion or implant failure	6 months +/- 2 weeks (survival analysis)
Secondary	Pain	Pain numerical rating scale (NRS) >3	6 months +/- 2 weeks
Secondary	Physical functioning	E.g. climbing stairs	6 months +/- 2 weeks