Completed
ESINFrom Bench to Bedside: Modification of Elastic Stable Intramedullary Nailing With a 3rd Nail in a Femoral Spiral Fracture Model and Its Transmission to Clinical Practice
What is being tested
3-Nail-ESIN in femoral shaft fractures
Procedure
Who is being recruted
Leg Injuries+1
+ Wounds and Injuries
+ Femoral Fractures
From 3 to 17 Years
+4 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: January 2009
Summary
Principal SponsorUniversity of Luebeck
Last updated: February 14, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2009
Actual date on which the first participant was enrolled.see above
Principal SponsorUniversity of Luebeck
Last updated: February 14, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 3 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Leg InjuriesWounds and InjuriesFemoral FracturesFractures, Bone
Criteria
2 inclusion criteria required to participate
Dislocated femoral fracture
ESIN osteosynthesis
2 exclusion criteria prevent from participating
No given informed consent
Other osteosynthesis than ESIN
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorProspectively all patients treated with the 3-nail-configuration for dislocated femoral shaft fractures were enrolled; 25 patients are planned, 18 could be enrolled Comparison will be with own previous data of patients treated with the "classical" 2-C-shaped ESIN-osteosynthesis
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center