Open tíbia FractureNCT06288139
Management of Open Fracture Tibia in Teenagers
An observational study of Open tíbia Fracture, run by Assiut University.
Trial summary
The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Open tíbia Fracture
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Feb 2025
- Phase
- Observational
- 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 10 to 19 years
- All sexes
- Child, Adult
Study population: All patients fulfilling the inclusion criteria presenting to our hospital during the study period will be included in the study in 2024
Who may be able to join
- All patients presenting with isolated open fracture tibia in teenagers (aged 10 to 19 Years old )
Who cannot join
- Patient who refuse to participate in the study
- Patient less than 10 or more than 19 years old
- Pathologic fractures
- Open Fracture tibia with other bony or organ injury
- Open fracture tibia with soft tissue loss or vascular injury
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Management of Open Fracture Tibia in Teenagers in Assiut University Hospital .
The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes
Read the detailed description
Tibial fractures are the third most common long bone fracture after the femur and forearm, representing 15% of all pediatric fractures Tibial fracture is a common injury in children, and it usually involves the diaphysis and distal metaphyseal region Open fracture tibia must be considered orthopedic emergencies due to the high risk of contamination, osteomyelitis, malformation, nonunion, and disability The anteromedial aspect of the tibia is subcutaneous with no overlying musculature for protection and the middle/distal tibia has no muscular origins, which can delay union in these areas The biology of the repair of fractures in children differs from that in adults in several ways. The soft tissues have excellent healing capacity, uncontaminated devitalised bone is salvageable and periosteum in children can regenerate bone in the presence of bone loss. Union is faster. Modalities of treatment of open fracture tibia in teenagers Including Closed reduction followed by a well- molded casting ,debridement followed by casting , utilization of external fixator (EF) remains a popular choice for open injuries, Severely comminuted and unstable fractures and those with significant soft tissue or vascular injury require external fixation However, pin tract infection (PTI) and refracture are common complications during the application of EF . Elastic Nail has also been reported with an acceptable for the treatment of open tibial fractures
, open reduction and internal fixation (ORIF) was reserved for situations in which an adequate reduction could not be obtained or maintained by conservative, Also Closed reduction and intramedullary nail fixation appropriate for the treatment of extraarticular distal tibial fractures .
- Conditions
- Open tíbia Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
Number
Measure number of teenagers who were admitted to Assiut university hospital with open fracture tibia with the different treatment methodology
Measured: Baseline
Secondary outcomes (3)
To evaluate treatment outcomes
Fracture healing
Measured: Baseline
Soft tissue healing
time taken for soft tissue to be healed
Measured: Baseline
Complication
Incidence and rate of complications
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Open tíbia FractureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Rashad Fawzy, Assiut University
- Investigators
- Kamal El gafari, prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288139
- Sponsor's protocol ID
- open fracture tibia
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang H, Liu H, Wu J, Li C, Zhou Y, Liu J, Ou L, Xiang L. Age, gender, and etiology differences of sports-related fractures in children and adolescents: A retrospective observational study. Medicine (Baltimore). 2019 Jan;98(4):e13961. doi: 10.1097/MD.0000000000013961.
PubMed 30681556Bartlett CS 3rd, Weiner LS, Yang EC. Treatment of type II and type III open tibia fractures in children. J Orthop Trauma. 1997 Jul;11(5):357-62. doi: 10.1097/00005131-199707000-00010.
PubMed 9294800Egol KA, Koval KJ, Zuckerman JD. Handbook of Fractures. 5th ed. Philadelphia, USA: Lippincott, Williams and Wilkins; 2015. [Google Scholar]
Louie KW. Management of open fractures of the lower limb. BMJ. 2009 Dec 17;339:b5092. doi: 10.1136/bmj.b5092. No abstract available.
PubMed 20019057Houdek MT, Wagner ER, Wyles CC, Sems SA, Moran SL. Reverse Medial Hemisoleus Flaps for Coverage of Distal Third Leg Wounds: A Technical Trick. J Orthop Trauma. 2016 Apr;30(4):e138-42. doi: 10.1097/BOT.0000000000000491.
PubMed 26606601Rexiti P, Zhang TC, Batuer C, Cao L. Orthopedic treatment for open fracture of lower extremities and soft tissue defects in young children and rapid rehabilitation after operation. Phys Sportsmed. 2020 May;48(2):161-164. doi: 10.1080/00913847.2019.1642810. Epub 2019 Aug 2.
PubMed 31317807Charalambous CP, Alvi F, Siddique I, Zenios M, Hirst P, Marshall P. Casting versus surgical fixation for grade IIIA open tibial diaphysial fractures in children: effect on the rate of infection and the need for secondary surgical procedures to promote bone union. Int Orthop. 2005 Dec;29(6):392-5. doi: 10.1007/s00264-005-0009-3. Epub 2005 Aug 10.
PubMed 16091949Norman D, Peskin B, Ehrenraich A, Rosenberg N, Bar-Joseph G, Bialik V. The use of external fixators in the immobilization of pediatric fractures. Arch Orthop Trauma Surg. 2002 Sep;122(7):379-82. doi: 10.1007/s00402-001-0383-2. Epub 2002 Feb 28.
PubMed 12228797Dai J, Wang X, Zhang F, Zhu L, Zhen Y. Treatment of distal metaphyseal tibia fractures using an external fixator in children. Medicine (Baltimore). 2019 Sep;98(36):e17068. doi: 10.1097/MD.0000000000017068.
PubMed 31490405Pandya NK, Edmonds EW. Immediate intramedullary flexible nailing of open pediatric tibial shaft fractures. J Pediatr Orthop. 2012 Dec;32(8):770-6. doi: 10.1097/BPO.0b013e318270468b.
PubMed 23147618Pandya NK. Flexible Intramedullary Nailing of Unstable and/or Open Tibia Shaft Fractures in the Pediatric Population. J Pediatr Orthop. 2016 Jun;36 Suppl 1:S19-23. doi: 10.1097/BPO.0000000000000754.
PubMed 27078231Im GI, Tae SK. Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plate and screws fixation. J Trauma. 2005 Nov;59(5):1219-23; discussion 1223. doi: 10.1097/01.ta.0000188936.79798.4e.
PubMed 16385303
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Open Fracture Tibia in Teenagers in Assiut University Hospital .
- ClinicalTrials.gov ID
- NCT06288139
- Acronym / sponsor ID
- open fracture tibia
- Conditions
- Open tíbia Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 1 Mar 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.
The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes
Detailed description
Tibial fractures are the third most common long bone fracture after the femur and forearm, representing 15% of all pediatric fractures Tibial fracture is a common injury in children, and it usually involves the diaphysis and distal metaphyseal region Open fracture tibia must be considered orthopedic emergencies due to the high risk of contamination, osteomyelitis, malformation, nonunion, and disability The anteromedial aspect of the tibia is subcutaneous with no overlying musculature for protection and the middle/distal tibia has no muscular origins, which can delay union in these areas The biology of the repair of fractures in children differs from that in adults in several ways. The soft tissues have excellent healing capacity, uncontaminated devitalised bone is salvageable and periosteum in children can regenerate bone in the presence of bone loss. Union is faster. Modalities of treatment of open fracture tibia in teenagers Including Closed reduction followed by a well- molded casting ,debridement followed by casting , utilization of external fixator (EF) remains a popular choice for open injuries, Severely comminuted and unstable fractures and those with significant soft tissue or vascular injury require external fixation However, pin tract infection (PTI) and refracture are common complications during the application of EF . Elastic Nail has also been reported with an acceptable for the treatment of open tibial fractures
, open reduction and internal fixation (ORIF) was reserved for situations in which an adequate reduction could not be obtained or maintained by conservative, Also Closed reduction and intramedullary nail fixation appropriate for the treatment of extraarticular distal tibial fractures .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All patients fulfilling the inclusion criteria presenting to our hospital during the study period will be included in the study in 2024
Key inclusion criteria (1 listed)
- All patients presenting with isolated open fracture tibia in teenagers (aged 10 to 19 Years old )
Key exclusion criteria (5 listed)
- Patient who refuse to participate in the study
- Patient less than 10 or more than 19 years old
- Pathologic fractures
- Open Fracture tibia with other bony or organ injury
- Open fracture tibia with soft tissue loss or vascular injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number
Time frame: Baseline
Measure number of teenagers who were admitted to Assiut university hospital with open fracture tibia with the different treatment methodology
3 secondary outcomes
To evaluate treatment outcomes
Time frame: Baseline
Soft tissue healing
Time frame: Baseline
Complication
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 30681556Wang H, Liu H, Wu J, Li C, Zhou Y, Liu J, Ou L, Xiang L. Age, gender, and etiology differences of sports-related fractures in children and adolescents: A retrospective observational study. Medicine (Baltimore). 2019 Jan;98(4):e13961. doi: 10.1097/MD.0000000000013961.
- Background: PubMed 9294800Bartlett CS 3rd, Weiner LS, Yang EC. Treatment of type II and type III open tibia fractures in children. J Orthop Trauma. 1997 Jul;11(5):357-62. doi: 10.1097/00005131-199707000-00010.
- BackgroundEgol KA, Koval KJ, Zuckerman JD. Handbook of Fractures. 5th ed. Philadelphia, USA: Lippincott, Williams and Wilkins; 2015. [Google Scholar]
- Background: PubMed 20019057Louie KW. Management of open fractures of the lower limb. BMJ. 2009 Dec 17;339:b5092. doi: 10.1136/bmj.b5092. No abstract available.
- Background: PubMed 26606601Houdek MT, Wagner ER, Wyles CC, Sems SA, Moran SL. Reverse Medial Hemisoleus Flaps for Coverage of Distal Third Leg Wounds: A Technical Trick. J Orthop Trauma. 2016 Apr;30(4):e138-42. doi: 10.1097/BOT.0000000000000491.
- Background: PubMed 31317807Rexiti P, Zhang TC, Batuer C, Cao L. Orthopedic treatment for open fracture of lower extremities and soft tissue defects in young children and rapid rehabilitation after operation. Phys Sportsmed. 2020 May;48(2):161-164. doi: 10.1080/00913847.2019.1642810. Epub 2019 Aug 2.
- Background: PubMed 16091949Charalambous CP, Alvi F, Siddique I, Zenios M, Hirst P, Marshall P. Casting versus surgical fixation for grade IIIA open tibial diaphysial fractures in children: effect on the rate of infection and the need for secondary surgical procedures to promote bone union. Int Orthop. 2005 Dec;29(6):392-5. doi: 10.1007/s00264-005-0009-3. Epub 2005 Aug 10.
- Background: PubMed 12228797Norman D, Peskin B, Ehrenraich A, Rosenberg N, Bar-Joseph G, Bialik V. The use of external fixators in the immobilization of pediatric fractures. Arch Orthop Trauma Surg. 2002 Sep;122(7):379-82. doi: 10.1007/s00402-001-0383-2. Epub 2002 Feb 28.
- Background: PubMed 31490405Dai J, Wang X, Zhang F, Zhu L, Zhen Y. Treatment of distal metaphyseal tibia fractures using an external fixator in children. Medicine (Baltimore). 2019 Sep;98(36):e17068. doi: 10.1097/MD.0000000000017068.
- Background: PubMed 23147618Pandya NK, Edmonds EW. Immediate intramedullary flexible nailing of open pediatric tibial shaft fractures. J Pediatr Orthop. 2012 Dec;32(8):770-6. doi: 10.1097/BPO.0b013e318270468b.
- Background: PubMed 27078231Pandya NK. Flexible Intramedullary Nailing of Unstable and/or Open Tibia Shaft Fractures in the Pediatric Population. J Pediatr Orthop. 2016 Jun;36 Suppl 1:S19-23. doi: 10.1097/BPO.0000000000000754.
- Background: PubMed 16385303Im GI, Tae SK. Distal metaphyseal fractures of tibia: a prospective randomized trial of closed reduction and intramedullary nail versus open reduction and plate and screws fixation. J Trauma. 2005 Nov;59(5):1219-23; discussion 1223. doi: 10.1097/01.ta.0000188936.79798.4e.
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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.
Kamal El gafari, prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Open tíbia Fracture, 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 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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?
Contact Mena Rashad, Resident (01226638111, Mena.15235660@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (time frame: Baseline). 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 NCT06288139, which also lists 12 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 1 Mar 2024.