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Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease
Lower Limb Fractures

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

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures




Primary Outcome Measures :
  1. Failure of internal fixation [ Time Frame: 6 months +/- 2 weeks (survival analysis) ]
    Failure of internal fixation due to nonunion or implant failure


Secondary Outcome Measures :
  1. Pain [ Time Frame: 6 months +/- 2 weeks ]
    Pain numerical rating scale (NRS) >3

  2. Physical functioning [ Time Frame: 6 months +/- 2 weeks ]
    E.g. climbing stairs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lower limb fractures.
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

Information from the National Library of Medicine

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


Locations
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Germany
Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim
Cologne, North-Rhine-Westfalia, Germany, 51109
Sponsors and Collaborators
University of Witten/Herdecke
Investigators
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Principal Investigator: Tim Mathes, Dr. University of Witten/Herdecke

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: Tim Mathes, Principal Investigator, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT03091114     History of Changes
Other Study ID Numbers: V01-A0
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tim Mathes, University of Witten/Herdecke:
fractures, risk prediction
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries