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Bifocal vs Trifocal External Bone Transport by Ilizarov Ring External Fixator in Lower Limbs

Bifocal Versus Trifocal External Bone Transport by Ilizarov Ring External Fixator as a Treatment Method for Posttraumatic Bone Defects More Than 5cm in Lower Extremities in Adults

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04486365
Enrollment
30
Registered
2020-07-24
Start date
2020-08-01
Completion date
2023-08-01
Last updated
2020-07-24

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

Conditions

Bone Loss

Keywords

bone transport / ilizarov ring external fixator

Brief summary

To compare between bifocal and trifocal external bone transport by ilizarov ring external fixator as a treatment method for posttraumatic bone defects more than 5cm in lower extremities regarding: * External fixation index . * The need of any further surgical procedures as debridement at docking site , the need of cancellous bone graft or the use of internal fixation. * Functional outcome, complication rate as well as limb length discrepancy.

Detailed description

Distraction osteogenesis is formation of new bone(regenerate bone) when bone segments undergo gradual, controlled separation. There are three treatment approaches by ilizarov ring external fixator according to number of bone osteotomies. First one is the monofocal approach with closure of defect without any osteotomies. Second one is the bifocal approach with a single osteotomy to create one transported bone segment between the osteotomy and the defect. Third one is the trifocal approach with two osteotomies creating two separate transported bone segments. Hypothetically, trifocal approach has shorter treatment time than bifocal one as it is a double level bone transport so closes the defect faster. However, there are other considerations as complications that may occur and the need of further surgical procedures and this is what will be discussed in this research.

Interventions

PROCEDUREBifocal bone transport.

The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.

PROCEDURETrifocal bone transport

The trifocal approach is two osteotomies creating two separate transported bone segments.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 1)Age from 18-60ys . 2)Posttraumatic bone defects more than 5 cm. 3)Lower extremity bone defects.

Exclusion criteria

* 1)Young pts \<18 or old pts\>60. 2)Post infectious or post-resection of a tumor bone defects. 3)Upper extremity bone defects.

Design outcomes

Primary

MeasureTime frameDescription
External fixation index12 to 15 monthsthe number of days the external fixator is attached to the bone per centimeter of length gained.

Contacts

Primary ContactKhaled Mohsen, Bachelor
kmm1821995@gmail.com01065699144
Backup ContactAhmed Ekram, MD
ahmed.osman@aun.edu.eg01012756356

Outcome results

None listed

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