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

March 27, 2022 updated by: Hossam Eldeen Ahmed Neyaz, Assiut University

Management of Open Tibial Fractures With Bone Loss Using Monorail Fixator Over Intramedullary Nail

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Participants
patients undergoes intramedullary nail with Limb Reconstruction System
Procedure: intramedullary nail with Limb Reconstruction System
bone transport by Limb Reconstruction System over intramedullary nail on fracture tibia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASAMI Scoring System
Time Frame: 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
1 year

Collaborators and Investigators

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

Sponsor

Assiut 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 (ANTICIPATED)

April 1, 2022

Primary Completion (ANTICIPATED)

April 1, 2024

Study Completion (ANTICIPATED)

February 1, 2025

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (ACTUAL)

March 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200694

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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