Clinical trial NCT03091114: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Limb Fractures
Keywords: fractures, risk prediction
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lower limb fractures.

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

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

Primary outcomes:
measure: Failure of internal fixation
timeFrame: 6 months +/- 2 weeks (survival analysis)
Secondary outcomes:
measure: Pain
timeFrame: 6 months +/- 2 weeks
measure: Physical functioning
timeFrame: 6 months +/- 2 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim
state: North-Rhine-Westfalia
Study officials:
affiliation: University of Witten/Herdecke
name: Tim Mathes, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.