Management of Open Fracture Tibia in Teenagers

Open tíbia Fracture Clinical Trial

Official title:

Management of Open Fracture Tibia in Teenagers in Assiut University Hospital .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06288139
• Other study ID #: open fracture tibia
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Mena Rashad, Resident
• Phone: 01226638111
• Email: Mena.15235660[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria :

• All patients presenting with isolated open fracture tibia in teenagers (aged 10 to 19 Years old )

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Open tíbia Fracture
• Tibial Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

Bartlett 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. — View Citation

Charalambous 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. — View Citation

Dai 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. — View Citation

Egol KA, Koval KJ, Zuckerman JD. Handbook of Fractures. 5th ed. Philadelphia, USA: Lippincott, Williams and Wilkins; 2015. [Google Scholar]

Houdek 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. — View Citation

Im 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. — View Citation

Louie KW. Management of open fractures of the lower limb. BMJ. 2009 Dec 17;339:b5092. doi: 10.1136/bmj.b5092. No abstract available. — View Citation

Norman 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. — View Citation

Pandya 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. — View Citation

Pandya 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. — View Citation

Rexiti 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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number	Measure number of teenagers who were admitted to Assiut university hospital with open fracture tibia with the different treatment methodology	Baseline
Secondary	To evaluate treatment outcomes	Fracture healing	Baseline
Secondary	Soft tissue healing	time taken for soft tissue to be healed	Baseline
Secondary	Complication	Incidence and rate of complications	Baseline