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

NCT ID: NCT04486365

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bifocal bone transport

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

Group Type ACTIVE_COMPARATOR

Bifocal bone transport.

Intervention Type PROCEDURE

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

Trifocal bone transport

The trifocal approach is two osteotomies creating two separate transported bone segments between osteotomy and defect.

Group Type ACTIVE_COMPARATOR

Trifocal bone transport

Intervention Type PROCEDURE

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

Interventions

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Bifocal bone transport.

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

Intervention Type PROCEDURE

Trifocal bone transport

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Khaled Mohsen Mohammed Ahmed

Resident physician in orthopedic surgery department.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Khaled Mohsen, Bachelor

Role: CONTACT

01065699144

Ahmed Ekram, MD

Role: CONTACT

01012756356

References

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Hansen M, Mehler D, Voltmer W, Rommens PM. [The extraarticular proximal tibial fractures]. Unfallchirurg. 2002 Oct;105(10):858-72. doi: 10.1007/s00113-002-0529-x. German.

Reference Type BACKGROUND
PMID: 12376892 (View on PubMed)

Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.

Reference Type BACKGROUND
PMID: 16814787 (View on PubMed)

Gaebler C, Berger U, Schandelmaier P, Greitbauer M, Schauwecker HH, Applegate B, Zych G, Vecsei V. Rates and odds ratios for complications in closed and open tibial fractures treated with unreamed, small diameter tibial nails: a multicenter analysis of 467 cases. J Orthop Trauma. 2001 Aug;15(6):415-23. doi: 10.1097/00005131-200108000-00006.

Reference Type BACKGROUND
PMID: 11514768 (View on PubMed)

Giannoudis PV, Papakostidis C, Roberts C. A review of the management of open fractures of the tibia and femur. J Bone Joint Surg Br. 2006 Mar;88(3):281-9. doi: 10.1302/0301-620X.88B3.16465. No abstract available.

Reference Type BACKGROUND
PMID: 16497997 (View on PubMed)

Other Identifiers

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Ilizarov ring external fixator

Identifier Type: -

Identifier Source: org_study_id

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