Uses of Titanium Nail in Pediatric Fractures

Short Term Functional and Radiological Outcomes of Using Double Short Titanium Elastic Nails in Treatment of Pediatric Distal Radius Fractures.

The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures.

Study Overview

• Status: Recruiting
• Conditions: Fracture of Distal End of Radius; Trauma Injury of Upper Extremity Forearm Multiple
• Intervention / Treatment: Procedure: Distal radius fracture fixation in pediatrics.

Detailed Description

Severely displaced distal radial fractures in children are generally considered unstable; especially when associated with total rupture of the periosteum. Although the remodeling potential of distal radial fractures is very good in childhood, a subgroup of severely displaced and unstable distal pediatric forearm fractures are candidates for operative fixation because acceptable reduction cannot be maintained in a conservative way. These injuries are usually candidates for closed reduction and minimal invasive fixation.

Operative osteosynthesis technique of pediatric wrist fractures are optimally minimally invasive, physeal sparing, and with acceptable reduction.

Most operative methods need complementary 4 to 6 weeks of postoperative immobilization by casting. Many of these techniques do not respect physeal plates. Both current available fixation techniques; modifications of Kirschner wiring or conventional elastic stable intramedullary nailing [ESIN]) have the same rate of mild complications. Growth disturbance is a rare, but represents a very rare severe complication of transepiphyseal wire placement.

Varga et al. Medicine (2017) 96:14[8] used modified ESIN method for operative treatment of severely displaced pediatric distal metaphyseal or metadiaphyseal radial fractures. With 2 short, prebent, retrograde elastic titanium nails inserted proximal to the distal radial physis, a very stable stabilization achieved without the need for a prolonged period of cast immobilization. The nails do not cross the physeal plates, so the possibility of postoperative physeal arrest is reduced.

their results:(the study shows a new technique in fixation of severely displaced pediatric distal radial fractures é more stable fixation,less pin track irritations and infections,early return to full range of motion within the sixth postoperative week, short removable splint was sufficient for early pain-free mobilization.

All the x-rays made 6 months postoperatively showed anatomic reduction, and there has been no sign of omic reduction, and there has been no sign of growth disturbance at the area of thece at the area of the distal radius) We conduct this study to evaluate the Short term functional and radiological outcomes of using double short titanium elastic nails in treatment of pediatric distal radius fractures.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Abdellah Desoky, MD; Phone Number: +201126002826; Email: mostafaabdelaah@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient Age ( 4 - 16 ) Years old.
• Both sex included .
• Simple or compound fractures (Grade I).
• Isolated fracture in the limb.
• Severely displaced fracture (Angulated).
• Recent and old distal radius fractures

Exclusion Criteria:

• Ages below 4 years or above 16 years.
• Associated with other fractures in the same limb.
• Compound fractures ( Grade II,III).
• Comminuted or Pathological fractures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pediatric distal radial fractures.; Pediatric traumatized patients aged between 4 to 16 years old who presented by distal radial fractures and need to go under operative management.	Procedure: Distal radius fracture fixation in pediatrics.; using double short titanium elastic nails in treatment of pediatric distal radius fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between usage of titanium nail and old methods	As old techniques used to reduce severely displaced fracture, the new technique assures better healing and full range motion.	2 Weeks up to 6 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Assuring more stability.	2 weeks up to 6 weeks

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Varga M, Jozsa G, Fadgyas B, Kassai T, Renner A. Short, double elastic nailing of severely displaced distal pediatric radial fractures: A new method for stable fixation. Medicine (Baltimore). 2017 Apr;96(14):e6532. doi: 10.1097/MD.0000000000006532.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: fractures; Pediatric Trauma; Double Titanium nail; Distal Radial Fractures; Intramedullary nail fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries
• Other Study ID Numbers: Titanium nail usage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No