Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

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

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.

Study Overview

• Status: Unknown
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Germany
  • North-Rhine-Westfalia
    • Cologne, North-Rhine-Westfalia, Germany, 51109
      • Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with lower limb fractures.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure of internal fixation	Failure of internal fixation due to nonunion or implant failure	6 months +/- 2 weeks (survival analysis)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain numerical rating scale (NRS) >3	6 months +/- 2 weeks
Physical functioning	E.g. climbing stairs	6 months +/- 2 weeks

Collaborators and Investigators

• Sponsor: University of Witten/Herdecke
• Investigators: Principal Investigator: Tim Mathes, Dr., University of Witten/Herdecke

Publications and helpful links

General Publications

• Prediger B, Tjardes T, Probst C, Heu-Parvaresch A, Glatt A, Dos Anjos DR, Bouillon B, Mathes T. Factors predicting failure of internal fixations of fractures of the lower limbs: a prospective cohort study. BMC Musculoskelet Disord. 2021 Sep 16;22(1):798. doi: 10.1186/s12891-021-04688-6.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: fractures, risk prediction
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: V01-A0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data on predictive factors and outcomes will be made available. Published as supplemental material open access (anticipated 12/2018).

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No