NCT01815658

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 21, 2013

Status Verified

March 1, 2013

Enrollment Period

3 months

First QC Date

March 11, 2013

Last Update Submit

March 19, 2013

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (1)

  • Bone healing

    Observed imaging proof of callus will indicate quality of bone healing.

    6 months

Study Arms (1)

Broken humerus shaft

Patients presenting with broken humerus shaft

Device: Carbon fiber intramedullary nail (PEEK-CF)

Interventions

Carbon fiber intramedullary nail (PEEK-CF)DEVICE

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

Broken humerus shaft

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting with broken humerus

You may qualify if:

  • Broken humerus shaft

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Yoram Folman, MD

CONTACT

972-4-6304738folman@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 21, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 21, 2013

Record last verified: 2013-03

Locations

IL(1)