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NCT01815658 Clinical Trial

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

Fractures, Bone Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01815658
Other study ID # HYMC-15-2013
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 11, 2013
Last updated March 19, 2013
Start date April 2013
Est. completion date July 2013

Study information
Verified date March 2013
Source Hillel Yaffe Medical Center
Contact Yoram Folman, MD
Phone 972-4-6304738
Email folman@hy.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Broken humerus shaft

Exclusion Criteria:

- All others

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Device:
• Carbon fiber intramedullary nail (PEEK-CF)
Carbon fiber polyether-ether-ketone (PEEK-CF) PICCOLE Nail - produced by Carbofix, Herzlyia, Israel.

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone healing Observed imaging proof of callus will indicate quality of bone healing. 6 months No
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