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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03212768
Other study ID # LEFA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date December 2018

Study information

Verified date June 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ankle fractures are among the most common osseous injuries to the lower extremity, and remain a significant source of morbidity for both the young and the elderly. Recent cross-national studies have shown a significant increase in the incidence and severity of ankle fractures among the elderly population.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- all types of trumatic ankle fractures due to low energy amenable to surgical open reduction and internal fixation .

Exclusion Criteria:

- previous surgery.

- Disorders of bone metabolism other than osteoprosis (ie, Paget disease , renal osteodystrophy , osteomalacia )

- Patient with moderate or severe congnitive impairment or patients with Parkinson disease or dementia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Trans-syndesmotic fixation
antromedial approach for medial malleolus fractures, posterolateral or direct lateral approach for fibula fractures, direct fixation of third malleolus by posterior approach, Trans-syndesmotic fixation ,cement augmentation and Tibiotalocalcaneal fusion

Locations

Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of recovery from the surgery of fractures 4 weeks
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