"Bio-logical" Carbon Fiber Intramedullary Nail Biomechanical Test and Preliminary Clinical Results

• Conditions: Fractures, Bone
• Interventions: Device: Carbon fiber intramedullary nail (PEEK-CF)

• Registration Number: NCT01815658
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-19
• Last Update Submitted: 2013-03-19
• Study First Posted: 2013-03-21
• Last Update Posted: 2013-03-21
• Study Start: 2013-04
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Broken humerus shaft

Exclusion Criteria

• All others

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Broken humerus shaft	Carbon fiber intramedullary nail (PEEK-CF)	Patients presenting with broken humerus shaft

Primary Outcome Measures

Name	Time	Method
Bone healing	6 months	Observed imaging proof of callus will indicate quality of bone healing.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel