Uses of Titanium Nail in Pediatric Fractures

NCT ID: NCT06276062

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-10-31

Brief Summary

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.

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.

Conditions

Trauma Injury of Upper Extremity Forearm Multiple; Fracture of Distal End of Radius

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Distal radius fracture fixation in pediatrics.

Intervention Type: PROCEDURE

using double short titanium elastic nails in treatment of pediatric distal radius fractures.

Interventions

Distal radius fracture fixation in pediatrics.

using double short titanium elastic nails in treatment of pediatric distal radius fractures.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Abdellah Desoky

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mostafa Abdellah Desoky, MD

Role: CONTACT

mostafaabdelaah@med.sohag.edu.eg

+201126002826

References

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.

Reference Type: BACKGROUND

PMID: 28383417 (View on PubMed)

Other Identifiers

Titanium nail usage

Identifier Type: -

Identifier Source: org_study_id