Uses of Titanium Nail in Pediatric Fractures

Fracture of Distal End of Radius Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276062
• Other study ID #: Titanium nail usage
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Sohag University
• Contact: Mostafa Abdellah Desoky, MD
• Phone: +201126002826
• Email: mostafaabdelaah[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arm Injuries
• Fracture of Distal End of Radius
• Fractures, Bone

Intervention

Procedure:
• Distal radius fracture fixation in pediatrics.
using double short titanium elastic nails in treatment of pediatric distal radius fractures.

Locations

Country	Name	City	State
Egypt	Sohag university	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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