Predictive Factors for Failure of Internal Fixations of L... | NCT03091114

Studies
Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures

NCT03091114

Sponsor

University of Witten/Herdecke

Status

Unknown status

Last Update Posted

Oct 9, 2018Actual

Enrollment

210Actual

Phase

Not provided

Conditions

Lower Limb Fractures

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2017Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Mar 13, 2017

First Submission Date that Met QC Criteria

Mar 20, 2017

First Posted Date

Mar 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2018

Last Update Posted Date

Oct 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tim Mathes, Principal Investigator, University of Witten/HerdeckePrincipal Investigator

Lead Sponsor

University of Witten/HerdeckeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with lower limb fractures.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim Mathes, Dr.	University of Witten/Herdecke	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim		Cologne	North-Rhine-Westfalia	51109	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34530793	Derived	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.

Type	Date	Date Unknown
Release	Jun 22, 2022
Reset	Apr 4, 2023