Bone Transport Through Induced Membrane vs Conventional Bone Transport in Management of Bone Defects of Lower Limbs

Bone Loss Clinical Trial

Official title:

Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05631951
• Other study ID #: FMASU MD57/2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomised controlled comparative study comparing bone transport through induced membrane (BTM) and conventional bone transport (BT) in management of bone defects in infected non united fractures of long bones of lower limbs (femur, tibia) as regard clinical, functional outcomes and possible complications.

Description:

A prospective randomised controlled study was conducted at Ain shams university hospitals. A total of 30 patients with infected non united fractures of long bones of lower limbs (femur and tibia) were divided randomly into 15 patients treated by bone transport through induced membrane technique (BTM) (Group A) and 15 patients treated by conventional bone transport technique (BT) (Group B)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Sex: both sexes.

• Age:18-60 yrs old.

• Lesion: tibial or femoral bone defects (>4 cm)

• Defects resulting from infected non-united fractures

Exclusion Criteria:

• Pathological and congenital defects

• Aseptic traumatic bone defects

• Defects less than 4 cm

• Multiple defects Pediatric age group

Related Conditions & MeSH terms

• Bone Loss

Intervention

Procedure:
• bone transport through induced membrane
Debridement done followed by external fixator and cement application to be followed by removal of cement (after 6 weeks) and start bone transport
• bone transport
Debridement done then external fixator was applied then bone transport started.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Marais LC, Ferreira N. Bone transport through an induced membrane in the management of tibial bone defects resulting from chronic osteomyelitis. Strategies Trauma Limb Reconstr. 2015 Apr;10(1):27-33. doi: 10.1007/s11751-015-0221-7. Epub 2015 Apr 4. — View Citation

Uzel AP, Lemonne F, Casoli V. Tibial segmental bone defect reconstruction by Ilizarov type bone transport in an induced membrane. Orthop Traumatol Surg Res. 2010 Apr;96(2):194-8. doi: 10.1016/j.rcot.2010.02.001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External fixation time	time from the initial application of the fixator until removal of fixator (in months)	through study completion, an average of 1 year
Primary	External fixation index	calculated by dividing the EFT (months) by the bone defect size (centimeters)	through study completion, an average of 1 year
Primary	Docking time	time taken (months) from end of bone transport till union of docking site (both with and without bone graft)	through study completion, an average of 1 year
Primary	Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System	scoring system for bone and functional results	through study completion, an average of 1 year
Primary	complications rate	number of complications in each group	through study completion, an average of 1 year
Primary	additional operations	number of additional operations in each group	through study completion, an average of 1 year