Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

• ClinicalTrials.gov Identifier: NCT03091114
• Recruitment Status: Unknown
• First Posted: March 27, 2017
• Last Update Posted: October 9, 2018
• Sponsor: University of Witten/Herdecke
• 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 9, 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

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 *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• 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

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).

• Current Responsible Party: Tim Mathes, University of Witten/Herdecke
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Witten/Herdecke
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Witten/Herdecke
• Verification Date: October 2018