Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures
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|ClinicalTrials.gov Identifier: NCT03091114|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : October 8, 2018
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.
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.
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:
- 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.
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.
|Condition or disease|
|Lower Limb Fractures|
|Study Type :||Observational|
|Actual Enrollment :||210 participants|
|Official Title:||Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures: a Prospective Cohort Study|
|Actual Study Start Date :||March 27, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- Failure of internal fixation [ Time Frame: 6 months +/- 2 weeks (survival analysis) ]Failure of internal fixation due to nonunion or implant failure
- Pain [ Time Frame: 6 months +/- 2 weeks ]Pain numerical rating scale (NRS) >3
- Physical functioning [ Time Frame: 6 months +/- 2 weeks ]E.g. climbing stairs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091114
|Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim|
|Cologne, North-Rhine-Westfalia, Germany, 51109|
|Principal Investigator:||Tim Mathes, Dr.||University of Witten/Herdecke|