Evaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-02-01

Brief Summary

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Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and require skin grafting, muscle pedicle graft or bone grafting. Sometimes the Participants end up with deformity, limb length discrepancy, joints stiffness, disuse osteoporosis and muscle atrophy after management

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Detailed Description

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Conditions

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Open Fracture Tibia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants

patients undergoes intramedullary nail with Limb Reconstruction System

Group Type OTHER

intramedullary nail with Limb Reconstruction System

Intervention Type PROCEDURE

bone transport by Limb Reconstruction System over intramedullary nail on fracture tibia

Interventions

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intramedullary nail with Limb Reconstruction System

bone transport by Limb Reconstruction System over intramedullary nail on fracture tibia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age from 18-60 years old.
* Open Grade II, Open Grade III (a \& b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
* Bone defect \< 10 cm.
* Patients with Injury severity score (ISS) \< 17.

Exclusion Criteria

* Massive bone defect \> 10 cm.
* Patients with ISS \> 17, polytrauma patient.
* Age \< 18 years old or \> 60 years old.
* Associated vascular injury ischemic limb.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes