Tibio-talo-calcaneal Fusion by Hindfoot Nail Versus Open Reduction and Internal Fixation in Treatment of Complex Fractures Distal Tibial and Fragility Ankle Fractures in Elderly

November 25, 2024 updated by: Amr Abdelgawad Mahmoud, Sohag University
Tibiotalar calcaneal fusion by hindfoot nail Vs open reduction and internal fixation in treatment of complex distal tibial fractures and ankle fragility ankle fractures in elderly

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed S Shaker, Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University hospitals
        • Contact:
          • Magdi M Amin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • pilon fractures complex distal tibial fractures ankle comminuted fractures age more than 65yrs osteoprotic fractures surgically fit patients

Exclusion Criteria:

Ankle fractures unimalleolar undisplaced Pathological fractures Young adults DVT Peripheral vascular diseases Age less than 65 Unfit patient for surgery

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fusion group
Procedure: Tibiotalar calcaneal fusion by hindfoot
Hindfoot nail for ankle fusion
Active Comparator: Open reduction and internal fixation group
Procedure: Tibiotalar calcaneal fusion by hindfoot
Hindfoot nail for ankle fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS American orthopedic foot and ankle score (Score for clinical effects of our intervention)
Time Frame: 2years
Score for clinical effects of our intervention
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-11-4MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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