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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00492154
Other study ID # SIM04-HMO-CTILL
Secondary ID
Status Terminated
Phase N/A
First received June 26, 2007
Last updated July 20, 2009
Start date September 2008

Study information

Verified date June 2009
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 18 Years
Eligibility Inclusion Criteria:

- Children that had had Ulna or Radius X-rays

- Signing Informed consent.

Exclusion Criteria:

- Unwillingness to sign informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

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