Management of Open Fracture Tibia in Teenagers

NCT06288139 | Not Yet Recruiting

• 1 other identifier: open fracture tibia
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Open tíbia Fracture

Outcome Measures

Primary Outcomes (1)

• Number

  Measure number of teenagers who were admitted to Assiut university hospital with open fracture tibia with the different treatment methodology

  Baseline

Secondary Outcomes (3)

• To evaluate treatment outcomes

  Baseline

• Soft tissue healing

  Baseline

• Complication

  Baseline

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients fulfilling the inclusion criteria presenting to our hospital during the study period will be included in the study in 2024

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• 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.

  PMID: 30681556 BACKGROUND

• 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.

  PMID: 9294800 BACKGROUND

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

  BACKGROUND

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

  PMID: 20019057 BACKGROUND

• 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.

  PMID: 26606601 BACKGROUND

• 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.

  PMID: 31317807 BACKGROUND

• 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.

  PMID: 16091949 BACKGROUND

• 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.

  PMID: 12228797 BACKGROUND

• 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.

  PMID: 31490405 BACKGROUND

• 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.

  PMID: 23147618 BACKGROUND

• 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.

  PMID: 27078231 BACKGROUND

• 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.

  PMID: 16385303 BACKGROUND

Study Officials

• Kamal El gafari, prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mena Rashad, Resident

CONTACT

01226638111; Mena.15235660@med.aun.edu.eg

Mohamed Yahia, Doctor

CONTACT

01111063532; Mohamedyahya@med.aun.edu.ef

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 1, 2024
• Study Start: March 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02