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NCT00541580 Clinical Trial

Comparative Results of Conservatively and Surgically Treated Adolescents With Triplane and Juvenile Tillaux Ankle Fractures After Skeletal Maturity

Ankle Injuries Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00541580
Other study ID # GOLD-001-HMO-CTIL
Secondary ID
Status Terminated
Phase N/A
First received October 7, 2007
Last updated September 15, 2011

Study information
Verified date September 2011
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

Triplane and Juvenile Tillaux fractures of the ankle are well known in adolescent pediatric population. It is widely accepted, that optimal treatment for displaced fractures is close or open reduction and fixation with screws under general anesthesia and under intraoperative fluoroscopy control. Usually a small degree of displacement (up to 2mm) is expected to be healed without any sequences. Until now, no evidence of ankle function and pain after skeletal maturity or long follow-up was published. More than that, no comparative study between operative and no operative treatment of mild and borderline displaced fractures were published.

The purpose of this study is to evaluate functional and radiographic results of operatively and conservatively treated patients after they reach skeletal maturity.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Sign informed consent.

Exclusion Criteria:

- Pregnancy

- Unwillingness to sign the informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization
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