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Clinical Trials/NCT04486365
NCT04486365
Unknown
Not Applicable

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

Assiut University0 sites30 target enrollmentStarted: August 1, 2020Last updated:
ConditionsBone Loss

Overview

Phase
Not Applicable
Enrollment
30
Primary Endpoint
External fixation index

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

External fixation index

Time Frame: 12 to 15 months

the number of days the external fixator is attached to the bone per centimeter of length gained.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khaled Mohsen Mohammed Ahmed

Resident physician in orthopedic surgery department.

Assiut University

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