Scaphoid FracturesNCT01249898
The Treatment and Intra-operative Imaging of Scaphoid Fracture Reduction and Fixation
An observational study of Scaphoid Fractures, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Scaphoid fractures are the most common carpal bone fractures, and second most common wrist fractures (second to distal radius fractures). Lack of proper immobilization or displacement of these fractures commonly results in fracture nonunion or malunion followed by the development of wrist post-traumatic… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Scaphoid Fractures
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that suffer fron Scaphoid fractures(nonunion included).
Who may be able to join
- Ages of 18 and 60 during the study period;
- Scaphoid fractures to be operatively reduced and fixated, including fracture non-unions;
- Signed informed consent.
Who cannot join
- Non-displaced fractures of the scaphoid.
- Soldiers in active military service.
- pregnant women
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organizaton
Jerusalem
Hadas Lemberg, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Scaphoid fractures are the most common carpal bone fractures, and second most common wrist fractures (second to distal radius fractures). Lack of proper immobilization or displacement of these fractures commonly results in fracture nonunion or malunion followed by the development of wrist post-traumatic osteoarthritis. In addition, proper reduction and fixation of these fractures are challenging to the most experienced hand surgeons.
The investigators are going to follow-up the patients population suffering from Scaphoid fractures(nonunion included) for one year. The investigators will evaluate this follow up results in two ways:
- Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation.
- Treatment of scaphoid fracture non-union.
- Conditions
- Scaphoid Fractures
- Keywords
- Fracture in the Scaphoid fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scaphoid 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
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249898
- Sponsor's protocol ID
- Luria004-HMO-CTIL
- Status last verified
- Feb 2014
- First submitted
- 28 Nov 2010
- 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
- The Treatment and Intra-operative Imaging of Scaphoid Fracture Reduction and Fixation
- ClinicalTrials.gov ID
- NCT01249898
- Acronym / sponsor ID
- Luria004-HMO-CTIL
- Conditions
- Scaphoid Fractures
- Keywords
- Fracture in the Scaphoid fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 30 Nov 2010 (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.
Scaphoid fractures are the most common carpal bone fractures, and second most common wrist fractures (second to distal radius fractures). Lack of proper immobilization or displacement of these fractures commonly results in fracture nonunion or malunion followed by the development of wrist post-traumatic osteoarthritis. In addition, proper reduction and fixation of these fractures are challenging to the most experienced hand surgeons.
The investigators are going to follow-up the patients population suffering from Scaphoid fractures(nonunion included) for one year. The investigators will evaluate this follow up results in two ways:
- Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation.
- Treatment of scaphoid fracture non-union.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that suffer fron Scaphoid fractures(nonunion included).
Key inclusion criteria (3 listed)
- Ages of 18 and 60 during the study period;
- Scaphoid fractures to be operatively reduced and fixated, including fracture non-unions;
- Signed informed consent.
Key exclusion criteria (3 listed)
- Non-displaced fractures of the scaphoid.
- Soldiers in active military service.
- pregnant women
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
Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation
Results and safety
Results are not available in the source record.
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.
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 Scaphoid 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 3 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation. 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 4 Mar 2014.