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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01815658

Enrollment

Registered

2013-03-21

Start date

2013-04-30

Completion date

2013-07-31

Last updated

2013-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures, Bone

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.

Interventions

DEVICECarbon fiber intramedullary nail (PEEK-CF)

Carbon fiber polyether-ether-ketone (PEEK-CF) PICCOLE Nail - produced by Carbofix, Herzlyia, Israel.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Broken humerus shaft

Exclusion criteria

* All others

Design outcomes

Primary

Measure	Time frame	Description
Bone healing	6 months	Observed imaging proof of callus will indicate quality of bone healing.

Countries

Israel

Contacts

Primary ContactYoram Folman, MD

folman@hy.health.gov.il972-4-6304738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026