Management of Open Fracture Tibia in Teenagers

NCT ID: NCT06288139

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Open tíbia Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mena Rashad Fawzy

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kamal El gafari, prof

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mena Rashad, Resident

Role: CONTACT

01226638111

Mohamed Yahia, Doctor

Role: CONTACT

01111063532

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30681556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9294800 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 20019057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26606601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31317807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16091949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12228797 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31490405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23147618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27078231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16385303 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

open fracture tibia

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gentamicin Open Tibia Study
NCT05157126 RECRUITING PHASE4
Training of Patients With Hip Fracture
NCT01174589 COMPLETED PHASE2
Early Weight Bearing in Distal Femur Fractures
NCT06806839 NOT_YET_RECRUITING NA
Surgery of the Pilon Fractures
NCT03367169 TERMINATED NA