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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
Sponsor:
Information provided by (Responsible Party):
Tim Mathes, University of Witten/Herdecke

Tracking Information
First Submitted Date March 13, 2017
First Posted Date March 27, 2017
Last Update Posted Date October 8, 2018
Actual Study Start Date March 27, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2017)
Failure of internal fixation [ Time Frame: 6 months +/- 2 weeks (survival analysis) ]
Failure of internal fixation due to nonunion or implant failure
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03091114 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 20, 2017)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures
Official Title Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures: a Prospective Cohort Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with lower limb fractures.
Condition Lower Limb Fractures
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 6, 2018)
210
Original Estimated Enrollment
 (submitted: March 20, 2017)
300
Estimated Study Completion Date December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03091114
Other Study ID Numbers V01-A0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: All data on predictive factors and outcomes will be made available. Published as supplemental material open access (anticipated 12/2018).
Responsible Party Tim Mathes, University of Witten/Herdecke
Study Sponsor University of Witten/Herdecke
Collaborators Not Provided
Investigators
Principal Investigator: Tim Mathes, Dr. University of Witten/Herdecke
PRS Account University of Witten/Herdecke
Verification Date October 2018