ClinicalTrials.gg
Status unknownNCT05296785Updated Apr 6, 2022

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

An interventional study of intramedullary nail with Limb Reconstruction System in Open Fracture Tibia, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Open Fracture Tibia

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03

In context

Fractures, Open

53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.

This study's planned enrollment of 20 is below the median of 90 across 40 interventional studies indexed under Fractures, Open.

Browse Fractures, Open studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Participants

    patients undergoes intramedullary nail with Limb Reconstruction System

    Procedure: intramedullary nail with Limb Reconstruction System

Interventions

  • Procedureintramedullary nail with Limb Reconstruction System

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

06

What researchers measure

Primary outcomes

  1. ASAMI Scoring System

    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

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2022; primary completion for Apr 2024, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2022
First posted
Mar 25, 2022
StartEst.
Apr 1, 2022
Primary completionEst.
Apr 1, 2024
CompletionEst.
Feb 1, 2025
Last update
Apr 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05296785
Lead sponsor
Assiut University
Responsible party
Hossam Eldeen Ahmed Neyaz (principle investigator, Assiut University) — Principal investigator
First posted
Mar 25, 2022
Start date
Apr 1, 2022 (estimated)
Primary completion
Apr 1, 2024 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Apr 6, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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