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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 26, 2007 | ||||
| Last Updated Date | July 20, 2009 | ||||
| Start Date ICMJE | September 2008 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00492154 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fracture of Distal Radius and Ulna Healed With Shortening of One Bone. Clinical Significance at Skeletal Maturity | ||||
| Official Title ICMJE | Fracture of Distal Radius and Ulna Healed With Shortening of One Bone. Clinical Significance at Skeletal Maturity | ||||
| Brief Summary | The fractures of distal forearm are the most common trauma in children. Sometimes one of the bones becomes shortened as a result of fracture fragments overlap. When some amount of shortening exists, concern regarding relationship of distal radio-ulnar joint (DRUJ) arises. The common opinion is expressed in one of the textbooks and is represented by one sentence, which usually one bone shortening is well tolerated, probably does not cause a problem, and does not have clinical significance. However, pathology of ulna plus or minus variants is well described and may cause ulno-carpal abutting syndrome or radiocarpal pain. This concern may lead to more aggressive approach in treatment of a fracture, with attempts to make an equal bone length. We did not find in the literature study that investigates this problem. We postulate that obvious shortening of one bone may cause an inequality of DRUJ and can be clinically significant. |
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| Detailed Description | We will evaluate the x-ray films of children that at the time of the injury were between the ages 1 day and 12 years. The selection of the x-ray films will be done based on the specific codes of the wrist x-rays (Ulna or Radius). The evaluation will be merely to children that were treated in our hospital from 1996 to 2000.We are aiming to find cases when the fractures were healed with 1cm or more of shortening of one of the forearm's bones (Radius or Ulna). We are going to compare these cases with another 20 patients with the same characteristics as the latter groups on the exception that their fractures were healed without shortening. The two groups will be matched by age, gender and the same diagnosis. These patients will be summoned to the clinic when they are adult in respect to the skeletal maturity. The patients will be evaluated, including clinical examination of the hand wrists (left and right), motion rang, motor muscle function, description of abnormalities if there are and x-ray of both wrists. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Forearm Injuries | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Unwillingness to sign informed consent. |
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| Gender | Both | ||||
| Ages | 15 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00492154 | ||||
| Responsible Party | Naum Simanovski, Hadassah Medical Organization | ||||
| Study ID Numbers ICMJE | SIM04-HMO-CTILL | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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