Femur FractureNCT06543901
Comparative Study Between (MIPO)Submuscular Plate Fixation of Fracture Femur and Conservative Management With Thomas Splint in Children From 5 to 8 Years Old: A Randomized Clinical Study
A study testing Submuscular plating and Traction and casting in people with Femur Fracture, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This randomized clinical study compares the outcomes of two treatment methods for femur fractures in children aged 5 to 8 years: Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation and conservative management using a Thomas splint. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Submuscular plating and Traction and casting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 May 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 5 to 8 years.
- Patients with midshaft or distal shaft femur fracture.
- Fracture pattern: transverse - oblique - spiral.
- Children must be < 45 KG.
Who cannot join
- Open fracture
- Any associated fracture in the same limb or in contralateral limb
- Associated serious internal organ injury or vascular injury
- Proximal, distal physeal femur fracture.
- Patient with pathological bone disease as osteogenesis imperfecta.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Alainy Hospital - Faculty of Medicine - Cairo University
Cairo, 11765
About this study
This randomized clinical study compares the outcomes of two treatment methods for femur fractures in children aged 5 to 8 years: Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation and conservative management using a Thomas splint. The study evaluates the efficacy, safety, and recovery outcomes of both techniques. Key parameters include healing time, functional outcomes, complication rates, and patient and caregiver satisfaction. The findings aim to provide evidence-based recommendations for the optimal management of femur fractures in young children, balancing the benefits and risks of surgical versus non-surgical approaches.
Read the detailed description
Introduction:
Femur fractures are common pediatric injuries that require effective treatment to ensure proper healing and prevent long-term complications. While conservative management with a Thomas splint is a traditional method, Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation has gained popularity due to its potential for faster recovery and reduced complications. This study aims to compare the outcomes of these two treatment modalities in children aged 5 to 8 years.
Objectives:
To compare the healing time between MIPO submuscular plate fixation and conservative management with Thomas splint.
To assess the functional outcomes of both treatment methods. To evaluate the complication rates associated with each treatment. To measure patient and caregiver satisfaction with each treatment approach.
Methods:
Study Design: Randomized clinical study. Participants: Children aged 5 to 8 years with femur fractures, meeting specific inclusion and exclusion criteria.
Randomization: Participants will be randomly assigned to either the MIPO submuscular plate fixation group or the conservative management with Thomas splint group.
Interventions:
MIPO Group: Surgical intervention using minimally invasive techniques to place a submuscular plate for fracture fixation.
Thomas Splint Group: Conservative management using a Thomas splint for immobilization and fracture healing.
Follow-Up: Regular follow-up visits at specified intervals to monitor healing, assess functional outcomes, and record any complications.
Outcome Measures:
Primary Outcome: Healing time, defined as the time from intervention to radiographic evidence of fracture union.
Secondary Outcomes:
Functional outcomes assessed using standardized pediatric orthopedic scoring systems.
Complication rates, including infection, malunion, nonunion, and reoperation rates.
Patient and caregiver satisfaction assessed through questionnaires and interviews.
- Conditions
- Femur Fracture
- Being tested
- Submuscular plating, Traction and casting
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submuscular platingProcedure or surgery
the patient was fixed with a submuscular plate
Traction and castingProcedure or surgery
the patient was placed on a traction with a thomas splint and then was casted with a hip spica
| Study group | Role | What they receive |
|---|---|---|
| Submuscular plate | Experimental | The patient underwent open reduction and internal fixation by being fixed with a submuscular plate Receives: Procedure: Submuscular plating |
| traction with a thomas splint and then casting | Active comparator | the patient was placed on traction with a thomas splint and then was casted in a spica cast Receives: Procedure: Traction and casting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bony union
we do sequential xrays until we can see a bony union
Measured: 6 weeks and 12 weeks
Secondary outcomes (1)
Any associated complications
such as pain, infection or failure of reduction
Measured: 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- 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
- This study employs a parallel-group randomized controlled trial (RCT) design. In this model, participants are randomly assigned to one of two groups: the intervention group or the control group. Each participant remains in their assigned group for the duration of the study, receiving either the intervention being tested (MIPO submuscular plate fixation) or the control treatment (conservative management with Thomas splint). This design allows for a direct comparison of the outcomes between the two groups, minimizing bias and ensuring the reliability of the results.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Sabry, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543901
- Sponsor's protocol ID
- MD-321-2021
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between (MIPO)Submuscular Plate Fixation of Fracture Femur and Conservative Management With Thomas Splint in Children From 5 to 8 Years Old: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06543901
- Acronym / sponsor ID
- MD-321-2021
- Conditions
- Femur Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 9 Aug 2024 (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 randomized clinical study compares the outcomes of two treatment methods for femur fractures in children aged 5 to 8 years: Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation and conservative management using a Thomas splint. The study evaluates the efficacy, safety, and recovery outcomes of both techniques. Key parameters include healing time, functional outcomes, complication rates, and patient and caregiver satisfaction. The findings aim to provide evidence-based recommendations for the optimal management of femur fractures in young children, balancing the benefits and risks of surgical versus non-surgical approaches.
Detailed description
Introduction:
Femur fractures are common pediatric injuries that require effective treatment to ensure proper healing and prevent long-term complications. While conservative management with a Thomas splint is a traditional method, Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation has gained popularity due to its potential for faster recovery and reduced complications. This study aims to compare the outcomes of these two treatment modalities in children aged 5 to 8 years.
Objectives:
To compare the healing time between MIPO submuscular plate fixation and conservative management with Thomas splint.
To assess the functional outcomes of both treatment methods. To evaluate the complication rates associated with each treatment. To measure patient and caregiver satisfaction with each treatment approach.
Methods:
Study Design: Randomized clinical study. Participants: Children aged 5 to 8 years with femur fractures, meeting specific inclusion and exclusion criteria.
Randomization: Participants will be randomly assigned to either the MIPO submuscular plate fixation group or the conservative management with Thomas splint group.
Interventions:
MIPO Group: Surgical intervention using minimally invasive techniques to place a submuscular plate for fracture fixation.
Thomas Splint Group: Conservative management using a Thomas splint for immobilization and fracture healing.
Follow-Up: Regular follow-up visits at specified intervals to monitor healing, assess functional outcomes, and record any complications.
Outcome Measures:
Primary Outcome: Healing time, defined as the time from intervention to radiographic evidence of fracture union.
Secondary Outcomes:
Functional outcomes assessed using standardized pediatric orthopedic scoring systems.
Complication rates, including infection, malunion, nonunion, and reoperation rates.
Patient and caregiver satisfaction assessed through questionnaires and interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a parallel-group randomized controlled trial (RCT) design. In this model, participants are randomly assigned to one of two groups: the intervention group or the control group. Each participant remains in their assigned group for the duration of the study, receiving either the intervention being tested (MIPO submuscular plate fixation) or the control treatment (conservative management with Thomas splint). This design allows for a direct comparison of the outcomes between the two groups, minimizing bias and ensuring the reliability of the results.
| Arm | Type | Receives |
|---|---|---|
| Submuscular plate | Experimental | Procedure: Submuscular platingThe patient underwent open reduction and internal fixation by being fixed with a submuscular plate |
| traction with a thomas splint and then casting | Active comparator | Procedure: Traction and castingthe patient was placed on traction with a thomas splint and then was casted in a spica cast |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children from 5 to 8 years.
- Patients with midshaft or distal shaft femur fracture.
- Fracture pattern: transverse - oblique - spiral.
- Children must be < 45 KG.
Key exclusion criteria (5 listed)
- Open fracture
- Any associated fracture in the same limb or in contralateral limb
- Associated serious internal organ injury or vascular injury
- Proximal, distal physeal femur fracture.
- Patient with pathological bone disease as osteogenesis imperfecta.
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 |
|---|---|---|
| Submuscular platingthe patient was fixed with a submuscular plate | Procedure or surgery | Submuscular plate |
| Traction and castingthe patient was placed on a traction with a thomas splint and then was casted with a hip spica | Procedure or surgery | traction with a thomas splint and then casting |
Primary outcome
Bony union
Time frame: 6 weeks and 12 weeks
we do sequential xrays until we can see a bony union
1 secondary outcome
Any associated complications
Time frame: 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submuscular plating and Traction and casting in people with Femur Fracture, run by Kasr El Aini Hospital 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 5 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: finished, as of the sponsor's last update on 9 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bony union (time frame: 6 weeks and 12 weeks). 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 9 Aug 2024.