Open Fracture TibiaNCT05296785
Evaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss
A study testing intramedullary nail with Limb Reconstruction System in people with Open Fracture Tibia, run by Assiut University.
Trial summary
Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Fracture Tibia
- What is being tested?
- intramedullary nail with Limb Reconstruction System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Feb 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18-60 years old.
- Open Grade II, Open Grade III (a \& b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
- Bone defect < 10 cm.
- Patients with Injury severity score (ISS) < 17.
Who cannot join
- Massive bone defect > 10 cm.
- Patients with ISS > 17, polytrauma patient.
- Age < 18 years old or > 60 years old.
- Associated vascular injury ischemic limb.
About this study
Official title: Management of Open Tibial Fractures With Bone Loss Using Monorail Fixator Over Intramedullary Nail
Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and require skin grafting, muscle pedicle graft or bone grafting. Sometimes the Participants end up with deformity, limb length discrepancy, joints stiffness, disuse osteoporosis and muscle atrophy after management
- Conditions
- Open Fracture Tibia
- Being tested
- intramedullary nail with Limb Reconstruction System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramedullary nail with Limb Reconstruction SystemProcedure or surgery
bone transport by Limb Reconstruction System over intramedullary nail on fracture tibia
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | patients undergoes intramedullary nail with Limb Reconstruction System Receives: Procedure: intramedullary nail with Limb Reconstruction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASAMI Scoring System
excellent : active , no limping good : active with one or more of : limp , stiffness , significant pain Fair : active with at least three of the following : limping , stiffness , significant pain , reflex sympathetic syndrome Poor : Inactive Failures : Amputations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Fracture TibiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Eldeen Ahmed Neyaz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296785
- Sponsor's protocol ID
- 17200694
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Open Tibial Fractures With Bone Loss Using Monorail Fixator Over Intramedullary Nail
- ClinicalTrials.gov ID
- NCT05296785
- Acronym / sponsor ID
- 17200694
- Conditions
- Open Fracture Tibia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 25 Mar 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.
Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and require skin grafting, muscle pedicle graft or bone grafting. Sometimes the Participants end up with deformity, limb length discrepancy, joints stiffness, disuse osteoporosis and muscle atrophy after management
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Procedure: intramedullary nail with Limb Reconstruction Systempatients undergoes intramedullary nail with Limb Reconstruction System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18-60 years old.
- Open Grade II, Open Grade III (a \& b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
- Bone defect < 10 cm.
- Patients with Injury severity score (ISS) < 17.
Key exclusion criteria (4 listed)
- Massive bone defect > 10 cm.
- Patients with ISS > 17, polytrauma patient.
- Age < 18 years old or > 60 years old.
- Associated vascular injury ischemic limb.
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 |
|---|---|---|
| intramedullary nail with Limb Reconstruction Systembone transport by Limb Reconstruction System over intramedullary nail on fracture tibia | Procedure or surgery | Participants |
Primary outcome
ASAMI Scoring System
Time frame: 1 year
excellent : active , no limping good : active with one or more of : limp , stiffness , significant pain Fair : active with at least three of the following : limping , stiffness , significant pain , reflex sympathetic syndrome Poor : Inactive Failures : Amputations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing intramedullary nail with Limb Reconstruction System in people with Open Fracture Tibia, run by Assiut University.
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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
ASAMI Scoring System (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022.