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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04486365
• Other study ID #: Ilizarov ring external fixator
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: Khaled Mohsen, Bachelor
• Phone: 01065699144
• Email: kmm1821995[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss

Intervention

Procedure:
• Bifocal bone transport.
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. Epub 2006 Jun 30. Review. — View Citation

Gaebler C, Berger U, Schandelmaier P, Greitbauer M, Schauwecker HH, Applegate B, Zych G, Vécsei 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. — View Citation

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. Review. — View Citation

Hansen M, Mehler D, Voltmer W, Rommens PM. [The extraarticular proximal tibial fractures]. Unfallchirurg. 2002 Oct;105(10):858-72. Review. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External fixation index	the number of days the external fixator is attached to the bone per centimeter of length gained.	12 to 15 months