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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05296785

Collaborator

(none)

Enrollment

Arm

34.1

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Open Fracture Tibia	Procedure: intramedullary nail with Limb Reconstruction System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hossam Eldeen Ahmed Neyaz, principle investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05296785

Other Study ID Numbers:

17200694

First Posted:

Mar 25, 2022

Last Update Posted:

Apr 6, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Fractures, Open

Study Results

No Results Posted as of Apr 6, 2022