Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

NCT03091114 | Unknown

• 1 other identifier: V01-A0
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Fractures

Keywords

fractures, risk prediction

Outcome Measures

Primary Outcomes (1)

• Failure of internal fixation

  Failure of internal fixation due to nonunion or implant failure

  6 months +/- 2 weeks (survival analysis)

Secondary Outcomes (2)

• Pain

  6 months +/- 2 weeks

• Physical functioning

  6 months +/- 2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lower limb fractures.

You may qualify if:

• 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

You may not qualify if:

• Periprosthetic fractures
• Insufficient knowledge of the German language
• Strong cognitive impairment

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (1)

Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim

Cologne, North-Rhine-Westfalia, 51109, Germany

Location

Related Publications (1)

• 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.

  PMID: 34530793 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Tim Mathes, Dr.

  University of Witten/Herdecke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 27, 2017
• Study Start: March 27, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)