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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06276062
Other study ID # Titanium nail usage
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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