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

• Sponsor: Ain Shams University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05631951
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 49
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bone Loss	Procedure: bone transport through induced membrane; Procedure: bone transport	N/A

Detailed 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)

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 30 patients were included and divided randomly into two equal groups: Group (A) will undergo BTM Group (B) will undergo BT Methods: I. Preoperative evaluation II. Operative interventions: A. Pre-operative: B. Operative interventions first step • resection of infected bone Second step: (A) Group A cement spacer and external fixator were applied then removal of cement spacer and metaphyseal osteotomy done (B)Group B external fixator was applied then metaphyseal osteotomy done C. Post-operative bone transport was started after latency of 7 days (from osteotomy) at rate of 1mm per day in 4 increments per day (rhythm of 0.25 mm every 6 hours) until reaching docking site.30 patients were included and divided randomly into two equal groups: Group (A) will undergo BTM Group (B) will undergo BTMethods:Preoperative evaluationII. Operative interventions:A. Pre-operative:Operative interventions first step • resection of infected boneSecond step:(A) Group A cement spacer and external fixator were applied then removal of cement spacer and metaphyseal osteotomy done (B)Group B external fixator was applied then metaphyseal osteotomy done C. Post-operative bone transport was started after latency of 7 days (from osteotomy) at rate of 1mm per day in 4 increments per day (rhythm of 0.25 mm every 6 hours) until reaching docking site.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bone transport through induced membrane First stage antibiotic impregnated cement spacer was applied to the bone defect external fixator was applied for 6-8 weeks ϖ Second stage 1.removal of cement spacer done 2.metaphyseal osteotomy done	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
Active Comparator: bone transport removal of all hardware resection of infected bone segments external fixator was applied metaphyseal osteotomy done	Procedure: bone transport; Debridement done then external fixator was applied then bone transport started.

Outcome Measures

Primary Outcome Measures

1. External fixation time [through study completion, an average of 1 year]

   time from the initial application of the fixator until removal of fixator (in months)

2. External fixation index [through study completion, an average of 1 year]

   calculated by dividing the EFT (months) by the bone defect size (centimeters)

3. Docking time [through study completion, an average of 1 year]

   time taken (months) from end of bone transport till union of docking site (both with and without bone graft)

4. Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System [through study completion, an average of 1 year]

   scoring system for bone and functional results

5. complications rate [through study completion, an average of 1 year]

   number of complications in each group

6. additional operations [through study completion, an average of 1 year]

   number of additional operations in each group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

• Study Chair: Mootaz F Thakeb, MD, Professor Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT05631951
• Other Study ID Numbers: FMASU MD57/2020
• First Posted: Nov 30, 2022
• Last Update Posted: Jan 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 9, 2023