Bone LossNCT05631951
Bone Transport Through Induced Membrane vs Conventional Bone Transport in Management of Bone Defects of Lower Limbs
A study testing bone transport through induced membrane and bone transport in people with Bone Loss, run by Ain Shams University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- bone transport through induced membrane and bone transport
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: both sexes.
- Age:18-60 yrs old.
- Lesion: tibial or femoral bone defects (>4 cm)
- Defects resulting from infected non-united fractures
Who cannot join
- Pathological and congenital defects
- Aseptic traumatic bone defects
- Defects less than 4 cm
- Multiple defects Pediatric age group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs
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.
Read the 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)
- Conditions
- Bone Loss
- Being tested
- bone transport through induced membrane, bone transport
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone transport through induced membraneProcedure or surgery
Debridement done followed by external fixator and cement application to be followed by removal of cement (after 6 weeks) and start bone transport
bone transportProcedure or surgery
Debridement done then external fixator was applied then bone transport started.
| Study group | Role | What they receive |
|---|---|---|
| bone transport through induced membrane | Active comparator | 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 Receives: Procedure: bone transport through induced membrane |
| bone transport | Active comparator | 1. removal of all hardware
2. resection of infected bone segments
3. external fixator was applied
4. metaphyseal osteotomy done Receives: Procedure: bone transport |
What is being measured
The primary outcome is the main question the study is designed to answer.
External fixation time
time from the initial application of the fixator until removal of fixator (in months)
Measured: through study completion, an average of 1 year
External fixation index
calculated by dividing the EFT (months) by the bone defect size (centimeters)
Measured: through study completion, an average of 1 year
Docking time
time taken (months) from end of bone transport till union of docking site (both with and without bone graft)
Measured: through study completion, an average of 1 year
Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System
scoring system for bone and functional results
Measured: through study completion, an average of 1 year
complications rate
number of complications in each group
Measured: through study completion, an average of 1 year
additional operations
number of additional operations in each group
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Jan 2019
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mootaz F Thakeb, MD, Study chair, Professor Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631951
- Sponsor's protocol ID
- FMASU MD57/2020
- Status last verified
- Jan 2023
- First submitted
- 1 Nov 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25840909Uzel 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.
PubMed 20417920
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs
- ClinicalTrials.gov ID
- NCT05631951
- Acronym / sponsor ID
- FMASU MD57/2020
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| bone transport through induced membrane | Active comparator | Procedure: bone transport through induced membraneFirst 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 | Active comparator | Procedure: bone transport1. removal of all hardware 2. resection of infected bone segments 3. external fixator was applied 4. metaphyseal osteotomy done |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sex: both sexes.
- Age:18-60 yrs old.
- Lesion: tibial or femoral bone defects (>4 cm)
- Defects resulting from infected non-united fractures
Key exclusion criteria (4 listed)
- Pathological and congenital defects
- Aseptic traumatic bone defects
- Defects less than 4 cm
- Multiple defects Pediatric age group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone transport through induced membraneDebridement done followed by external fixator and cement application to be followed by removal of cement (after 6 weeks) and start bone transport | Procedure or surgery | bone transport through induced membrane |
| bone transportDebridement done then external fixator was applied then bone transport started. | Procedure or surgery | bone transport |
Primary outcome
External fixation time
Time frame: through study completion, an average of 1 year
time from the initial application of the fixator until removal of fixator (in months)
External fixation index
Time frame: through study completion, an average of 1 year
calculated by dividing the EFT (months) by the bone defect size (centimeters)
Docking time
Time frame: 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)
Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System
Time frame: through study completion, an average of 1 year
scoring system for bone and functional results
complications rate
Time frame: through study completion, an average of 1 year
number of complications in each group
additional operations
Time frame: through study completion, an average of 1 year
number of additional operations in each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Background: PubMed 25840909Marais 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.
- Background: PubMed 20417920Uzel 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.
- Individual participant dataSharing planned: No
Related trials for Bone Loss
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mootaz F Thakeb, MD study chair
Professor Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone transport through induced membrane and bone transport in people with Bone Loss, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External fixation time (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631951, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.