FracturesNCT00355420
Evaluation of the Change in Length of the Leg in Children After Treatment of Femur Fractures.
An observational study of Fractures, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Femur fractures are a common injury in the Pediatric population. Despite their high incidence little do we know about the long term implications on the bones' length. Our main goal is to clarify this obscure issue by assessing the femoral and tibial length as determined by the fractures, measuring techniques and… Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Fractures
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2006to not given
- 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 Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children that sufferinf from LLD
Who may be able to join
- Males between the ages 0-16.
- Females between the ages 0-14.
- Signed Informed consent
Who cannot join
- A refusal by the patient or his legal guardian to continue the follow-up with the
- Pediatric Orthopedic clinic, or to have the CT scanograms.
- Patients with severe contractures in the lower extremities
- Patients with multiple lower extremity fractures
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Change in Length of the Femur and Tibia in Children After Treatment of Femur Fractures With External Fixators, Plaster of Paris or Internal Fixation
Femur fractures are a common injury in the Pediatric population. Despite their high incidence little do we know about the long term implications on the bones' length. Our main goal is to clarify this obscure issue by assessing the femoral and tibial length as determined by the fractures, measuring techniques and treatment modalities
- Conditions
- Fractures
- Medical subject headings
- Fractures, Bone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ron Lamdan, Dr., Principal investigator, Hadassah Medical OrganizationShlomo Porat, Prof., Study chair, Hadassah Medical OrganizationNaum Simanovski, Dr., Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355420
- Sponsor's protocol ID
- LLD01-HMO-CTIL
- Status last verified
- Mar 2013
- First submitted
- 20 Jul 2006
- Last updated
- 4 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Change in Length of the Femur and Tibia in Children After Treatment of Femur Fractures With External Fixators, Plaster of Paris or Internal Fixation
- ClinicalTrials.gov ID
- NCT00355420
- Acronym / sponsor ID
- LLD01-HMO-CTIL
- Conditions
- Fractures
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 21 Jul 2006 (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.
Femur fractures are a common injury in the Pediatric population. Despite their high incidence little do we know about the long term implications on the bones' length. Our main goal is to clarify this obscure issue by assessing the femoral and tibial length as determined by the fractures, measuring techniques and treatment modalities
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children that sufferinf from LLD
Key inclusion criteria (3 listed)
- Males between the ages 0-16.
- Females between the ages 0-14.
- Signed Informed consent
Key exclusion criteria (5 listed)
- A refusal by the patient or his legal guardian to continue the follow-up with the
- Pediatric Orthopedic clinic, or to have the CT scanograms.
- Patients with severe contractures in the lower extremities
- Patients with multiple lower extremity fractures
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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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.
Ron Lamdan, Dr. principal investigator
Hadassah Medical Organization
Shlomo Porat, Prof. study chair
Hadassah Medical Organization
Naum Simanovski, Dr. study director
Hadassah Medical Organization
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, run by Hadassah Medical Organization 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 4 Mar 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 4 Mar 2014.