Suspended
"Bio-logical" Carbon Fiber Intramedullary Nail Biomechanical Test and Preliminary Clinical Results
What is being collected
Device Data
Collected from past medical records and data - RetrospectiveDevice
Who is being recruted
Wounds and Injuries
+ Fractures, Bone
From 18 to 70 Years
+2 Eligibility Criteria
How is the trial designed
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Observational
Study Start: April 2013
Summary
Principal SponsorHillel Yaffe Medical Center
Study ContactYoram Folman, MDMore contacts
Last updated: March 21, 2013Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.The aim of this study is to present a novel Intramedullary Nail (IMN) made of CFR - PEED composite, that is biomechanically tailored to closely match cortical bone. This IMN should promote fracture healing and prevent stress shielding osteopenia. Case records of patients with humurus shaft fracture will be retrospectively reviewed to determine whether the implant promotes bone healing.
Principal SponsorHillel Yaffe Medical Center
Study ContactYoram Folman, MDMore contacts
Last updated: March 21, 2013Sourced 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
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.
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 18 to 70 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
Wounds and InjuriesFractures, Bone
Criteria
1 inclusion criteria required to participate
Broken humerus shaft
1 exclusion criteria prevent from participating
All others
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
Study Objectives
Primary 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
SuspendedOne Study Center