FracturePhase 1/2NCT00648479
New Method for Distal Interlocking of Cannulated Intramedullary Nails
A Phase 1/2 study testing The Guiding Star and fluoroscopy (OEC 9800 - General Electric) in people with Fracture, run by Hadassah Medical Organization.
Trial summary
We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fracture
- What is being tested?
- The Guiding Star and fluoroscopy (OEC 9800 - General Electric)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing Informed consent.
- Conscious patients.
Who cannot join
- Hemodynamic Instability.
- Multiple system injuries.
- Pregnancy.
- Soldiers.
About this study
We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study.
Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:"The Guiding star" method.
The allocation will be random.
- Conditions
- Fracture
- Being tested
- The Guiding Star, fluoroscopy (OEC 9800 - General Electric)
- Keywords
- Fracture Fixation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Guiding StarDevice
fluoroscopy (OEC 9800 - General Electric)Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: The Guiding Star |
| 2 | Active comparator | Not described Receives: Device: fluoroscopy (OEC 9800 - General Electric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the outcome will be asses using regular fluoroscopy in the operation room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
Why it stopped: the company does not want to proceed yet with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648479
- Sponsor's protocol ID
- EKL-001-HMO-CTIL
- Status last verified
- Dec 2011
- First submitted
- 17 Mar 2008
- Last updated
- 28 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Method for Distal Interlocking of Cannulated Intramedullary Nails
- ClinicalTrials.gov ID
- NCT00648479
- Acronym / sponsor ID
- EKL-001-HMO-CTIL
- Conditions
- Fracture
- Keywords
- Fracture Fixation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the company does not want to proceed yet with the study
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 1 Apr 2008 (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.
We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study.
Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:"The Guiding star" method.
The allocation will be random.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: The Guiding Star |
| 2 | Active comparator | Device: fluoroscopy (OEC 9800 - General Electric) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signing Informed consent.
- Conscious patients.
Key exclusion criteria (4 listed)
- Hemodynamic Instability.
- Multiple system injuries.
- Pregnancy.
- Soldiers.
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 |
|---|---|---|
| The Guiding Star | Device | 1 |
| fluoroscopy (OEC 9800 - General Electric) | Device | 2 |
Primary outcome
the outcome will be asses using regular fluoroscopy in the operation room.
Results and safety
The study was stopped early (reason given: the company does not want to proceed yet with the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing The Guiding Star and fluoroscopy (OEC 9800 - General Electric) in people with Fracture, run by Hadassah Medical Organization.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the company does not want to proceed yet with the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the outcome will be asses using regular fluoroscopy in the operation room.. 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 28 Dec 2011; AzTrials last refreshed its copy on 6 Nov 2026.