Bone Transport Through Induced Membrane vs Conventional Bone Transport in Management of Bone Defects of Lower Limbs
NCT ID: NCT05631951
Last Updated: 2023-01-09
Study Results
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-01-01
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
NONE
Study Groups
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bone transport through induced membrane
First stage
1. antibiotic impregnated cement spacer was applied to the bone defect
2. external fixator was applied for 6-8 weeks ϖ Second stage
1.removal of cement spacer done 2.metaphyseal osteotomy done
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
1. removal of all hardware
2. resection of infected bone segments
3. external fixator was applied
4. metaphyseal osteotomy done
bone transport
Debridement done then external fixator was applied then bone transport started.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age:18-60 yrs old.
* Lesion: tibial or femoral bone defects (\>4 cm)
* Defects resulting from infected non-united fractures
Exclusion Criteria
* Aseptic traumatic bone defects
* Defects less than 4 cm
* Multiple defects Pediatric age group
18 Years
60 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Mootaz F Thakeb, MD
Role: STUDY_CHAIR
Professor Ain Shams University
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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References
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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.
Other Identifiers
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FMASU MD57/2020
Identifier Type: -
Identifier Source: org_study_id
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