NCT03212768

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

July 7, 2017

Last Update Submit

June 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of recovery from the surgery of fractures

    4 weeks

Interventions

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with Grossly displaced fracture-dislocations

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 11, 2017

Study Start

May 1, 2018

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations