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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05296785
Enrollment
20
Registered
2022-03-25
Start date
2022-04-01
Completion date
2025-02-01
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Fracture Tibia

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

Interventions

PROCEDUREintramedullary nail with Limb Reconstruction System

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
ASAMI Scoring System1 yearexcellent : 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026