Proximal Third Tibial Shaft Fractures in ChildrenNCT06500325
Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children.
A study testing retrograde titanium elastic nails for fixation of proximal third tibial shaft fractures in children in people with Proximal Third Tibial Shaft Fractures in Children, run by Sohag University at 1 site in Egypt.
Trial summary
Pediatric tibial shaft fracture is the third most common pediatric long bone fracture after fracture of femur and forearm, representing 15% of all pediatric fractures. Closed reduction and casting is the standard of care for stable and minimally displaced fracture of the tibia in pediatric age group. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Proximal Third Tibial Shaft Fractures in Children
- What is being tested?
- retrograde titanium elastic nails for fixation of proximal third tibial shaft fractures in children
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Oct 2024
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion Criteria included children are patients presented with traumatic proximal shaft tibia fracture closed or open up to Gustillo grade II and patients between 4 and 12.
Who cannot join
- Exclusion criteria excluded children presented with Gustillo grade III A, B \& C open fractures and pathological fractures.
Trial locations and contacts
1 site in 1 country.
Marawan S Mohamed, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Pediatric tibial shaft fracture is the third most common pediatric long bone fracture after fracture of femur and forearm, representing 15% of all pediatric fractures. Closed reduction and casting is the standard of care for stable and minimally displaced fracture of the tibia in pediatric age group. Treatment of pediatric fractures dramatically changed in 1982. The goals are to stabilize the fracture, control limb length, alignment, rotation, instability, promote bone healing, and minimize the morbidity and complications for the child and his/her family. Titanium elastic nails (TENs) fixation was originally meant as an ideal treatment method for femoral shaft fractures, but was gradually applied to other long bones diaphysial fractures in children, as it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications.
Over the past 20 years, pediatric orthopedic surgeons have tried a variety of methods to treat pediatric lower limb fractures to avoid prolonged immobilization and complications. Each method has had its own complications: cast immobilization alone or following traction had resulted in limb-length discrepancy, angulations, rotational deformity, psychological and economic complications. External fixation had resulted in pin-tract infection, loss of knee range of motion, delayed union, non-union, and refracture after fixator removal. TENs work by balancing the forces between the two opposing flexible implants. To achieve this balance, the nail diameter should be 40% of the narrowest canal diameter or more. The nails should assume a double-C construct. They should have similar smooth curve and same level entry points.
Ligier et al and Flynn et al have reported that TENs can give rotational stability if good care is taken intra-operatively during nail insertion and postoperatively, especially for comminuted, spiral, and long oblique fractures.
- Being tested
- retrograde titanium elastic nails for fixation of proximal third tibial shaft fractures in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde titanium elastic nails for fixation of proximal third tibial shaft fractures in childrenProcedure or surgery
Two TENs were used in all cases using the double-C construct in most cases to gain three point of fixation. The starting point for nail insertion is 1.5-2.0 cm proximal to the physis of distal tibia. Both nails are then inserted through the entry holes and advanced to pass the level of the fracture site to achieve fixation. The two incisions for nail entry are closed in a layered fashion, and the wounds are well padded with gauze.
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometry of knee and ankle joints range of motion (ROM)
Goniometry involves using a goniometer, which is a specialized protractor-like device, to measure the angles of movement at joints such as the knee and ankle.
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 posted15 Jul 2024
- Study start1 Oct 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Proximal Third Tibial Shaft Fractures in ChildrenStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Youssery ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500325
- Sponsor's protocol ID
- Soh-Med-20-06-12MS
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel NK, Horstman J, Kuester V, Sambandam S, Mounasamy V. Pediatric Tibial Shaft Fractures. Indian J Orthop. 2018 Sep-Oct;52(5):522-528. doi: 10.4103/ortho.IJOrtho_486_17.
PubMed 30237610Buechsenschuetz KE, Mehlman CT, Shaw KJ, Crawford AH, Immerman EB. Femoral shaft fractures in children: traction and casting versus elastic stable intramedullary nailing. J Trauma. 2002 Nov;53(5):914-21. doi: 10.1097/00005373-200211000-00017.
PubMed 12435943Ligier JN, Metaizeau JP, Prevot J, Lascombes P. Elastic stable intramedullary nailing of femoral shaft fractures in children. J Bone Joint Surg Br. 1988 Jan;70(1):74-7. doi: 10.1302/0301-620X.70B1.3339064.
PubMed 3339064El-Adl G, Mostafa MF, Khalil MA, Enan A. Titanium elastic nail fixation for paediatric femoral and tibial fractures. Acta Orthop Belg. 2009 Aug;75(4):512-20.
PubMed 19774819
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Retrograde Titanium Elastic Nails for Fixation of Proximal Third Tibial Shaft Fractures in Children.
- ClinicalTrials.gov ID
- NCT06500325
- Acronym / sponsor ID
- Soh-Med-20-06-12MS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 15 Jul 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.
Pediatric tibial shaft fracture is the third most common pediatric long bone fracture after fracture of femur and forearm, representing 15% of all pediatric fractures. Closed reduction and casting is the standard of care for stable and minimally displaced fracture of the tibia in pediatric age group. Treatment of pediatric fractures dramatically changed in 1982. The goals are to stabilize the fracture, control limb length, alignment, rotation, instability, promote bone healing, and minimize the morbidity and complications for the child and his/her family. Titanium elastic nails (TENs) fixation was originally meant as an ideal treatment method for femoral shaft fractures, but was gradually applied to other long bones diaphysial fractures in children, as it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications.
Over the past 20 years, pediatric orthopedic surgeons have tried a variety of methods to treat pediatric lower limb fractures to avoid prolonged immobilization and complications. Each method has had its own complications: cast immobilization alone or following traction had resulted in limb-length discrepancy, angulations, rotational deformity, psychological and economic complications. External fixation had resulted in pin-tract infection, loss of knee range of motion, delayed union, non-union, and refracture after fixator removal. TENs work by balancing the forces between the two opposing flexible implants. To achieve this balance, the nail diameter should be 40% of the narrowest canal diameter or more. The nails should assume a double-C construct. They should have similar smooth curve and same level entry points.
Ligier et al and Flynn et al have reported that TENs can give rotational stability if good care is taken intra-operatively during nail insertion and postoperatively, especially for comminuted, spiral, and long oblique fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inclusion Criteria included children are patients presented with traumatic proximal shaft tibia fracture closed or open up to Gustillo grade II and patients between 4 and 12.
Key exclusion criteria (1 listed)
- Exclusion criteria excluded children presented with Gustillo grade III A, B \& C open fractures and pathological fractures.
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 |
|---|---|---|
| retrograde titanium elastic nails for fixation of proximal third tibial shaft fractures in childrenTwo TENs were used in all cases using the double-C construct in most cases to gain three point of fixation. The starting point for nail insertion is 1.5-2.0 cm proximal to the physis of distal tibia. Both nails are then inserted through the entry holes and advanced to pass the level of the fracture site to achieve fixation. The two incisions for nail entry are closed in a layered fashion, and the wounds are well padded with gauze. | Procedure or surgery | – |
Primary outcome
Goniometry of knee and ankle joints range of motion (ROM)
Time frame: 1 year
Goniometry involves using a goniometer, which is a specialized protractor-like device, to measure the angles of movement at joints such as the knee and ankle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 30237610Patel NK, Horstman J, Kuester V, Sambandam S, Mounasamy V. Pediatric Tibial Shaft Fractures. Indian J Orthop. 2018 Sep-Oct;52(5):522-528. doi: 10.4103/ortho.IJOrtho_486_17.
- Background: PubMed 12435943Buechsenschuetz KE, Mehlman CT, Shaw KJ, Crawford AH, Immerman EB. Femoral shaft fractures in children: traction and casting versus elastic stable intramedullary nailing. J Trauma. 2002 Nov;53(5):914-21. doi: 10.1097/00005373-200211000-00017.
- Background: PubMed 3339064Ligier JN, Metaizeau JP, Prevot J, Lascombes P. Elastic stable intramedullary nailing of femoral shaft fractures in children. J Bone Joint Surg Br. 1988 Jan;70(1):74-7. doi: 10.1302/0301-620X.70B1.3339064.
- Background: PubMed 19774819El-Adl G, Mostafa MF, Khalil MA, Enan A. Titanium elastic nail fixation for paediatric femoral and tibial fractures. Acta Orthop Belg. 2009 Aug;75(4):512-20.
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.
Marawan S Mohamed, lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retrograde titanium elastic nails for fixation of proximal third tibial shaft fractures in children in people with Proximal Third Tibial Shaft Fractures in Children, run by Sohag 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 1 inclusion and 1 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 15 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mOHAMED Y Ahmed, resident (01011367165, mohamed_yousry_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometry of knee and ankle joints range of motion (ROM) (time frame: 1 year). 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 NCT06500325, which also lists 4 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 15 Jul 2024.