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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

NCT ID: NCT06709365

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2026-10-30

Brief Summary

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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

Detailed Description

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Conditions

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Fragility Ankle Fractures and Complex Distal Tibial Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fusion group

Group Type ACTIVE_COMPARATOR

Tibiotalar calcaneal fusion by hindfoot

Intervention Type PROCEDURE

Hindfoot nail for ankle fusion

Open reduction and internal fixation group

Group Type ACTIVE_COMPARATOR

Tibiotalar calcaneal fusion by hindfoot

Intervention Type PROCEDURE

Hindfoot nail for ankle fusion

Interventions

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Tibiotalar calcaneal fusion by hindfoot

Hindfoot nail for ankle fusion

Intervention Type PROCEDURE

Eligibility Criteria

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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

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Minimum Eligible Age

1 Year

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Amr Abdelgawad Mahmoud

assistant lecturer of orthopaedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospitals

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr A Mahmoud, Assistant lecturer

Role: CONTACT

[email protected]
01066180172

Ahmed S Shaker, Professor

Role: CONTACT

Facility Contacts

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Magdi M Amin

Role: primary

Other Identifiers

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Soh-Med-24-11-4MD

Identifier Type: -

Identifier Source: org_study_id