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

Not Applicable

Not yet recruiting

• Conditions: Open Fracture Tibia
• Interventions: Procedure: intramedullary nail with Limb Reconstruction System

• Registration Number: NCT05296785
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Last Update Submitted: 2022-03-27
• Study Start: 2022-04-01
• Last Update Posted: 2022-04-06
• Primary Completion: 2024-04-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	intramedullary nail with Limb Reconstruction System	patients undergoes intramedullary nail with Limb Reconstruction System

Primary Outcome Measures

Name	Time	Method
ASAMI Scoring System	1 year	excellent : active , no limping good : active with one or more of : limp , stiffness , significant pain Fair : active with at least three of the following : limping , stiffness , significant pain , reflex sympathetic syndrome Poor : Inactive Failures : Amputations