Fractures, BoneNCT01815658
"Bio-logical" Carbon Fiber Intramedullary Nail Biomechanical Test and Preliminary Clinical Results
An observational study of Fractures, Bone, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- Carbon fiber intramedullary nail (PEEK-CF)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with broken humerus
Who may be able to join
- Broken humerus shaft
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Yoram Folman, MD
Alex Bionenko, MD
About this study
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.
- Conditions
- Fractures, Bone
- Being tested
- Carbon fiber intramedullary nail (PEEK-CF)
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon fiber intramedullary nail (PEEK-CF)Device
Carbon fiber polyether-ether-ketone (PEEK-CF) PICCOLE Nail - produced by Carbofix, Herzlyia, Israel.
| Study group | Role | What they receive |
|---|---|---|
| Broken humerus shaft | Patients presenting with broken humerus shaft Receives: Device: Carbon fiber intramedullary nail (PEEK-CF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing
Observed imaging proof of callus will indicate quality of bone healing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815658
- Sponsor's protocol ID
- HYMC-15-2013
- Status last verified
- Mar 2013
- First submitted
- 11 Mar 2013
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Bio-logical" Carbon Fiber Intramedullary Nail Biomechanical Test and Preliminary Clinical Results
- ClinicalTrials.gov ID
- NCT01815658
- Acronym / sponsor ID
- HYMC-15-2013
- Conditions
- Fractures, Bone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Broken humerus shaft | – | Device: Carbon fiber intramedullary nail (PEEK-CF)Patients presenting with broken humerus shaft |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with broken humerus
Key inclusion criteria (1 listed)
- Broken humerus shaft
Key exclusion criteria (1 listed)
- All others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon fiber intramedullary nail (PEEK-CF)Carbon fiber polyether-ether-ketone (PEEK-CF) PICCOLE Nail - produced by Carbofix, Herzlyia, Israel. | Device | Broken humerus shaft |
Primary outcome
Bone healing
Time frame: 6 months
Observed imaging proof of callus will indicate quality of bone healing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoram Folman, MD (972-4-6304738, folman@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone healing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.