Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-12
Brief Title:
Management of Pediatric Distal Radius Fractures Conservative Treatment Versus Surgical Reduction
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Management of Pediatric Distal Radius Fractures Conservative Treatment Versus Surgical Reduction - a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare functional and radiological assessment between two groups of children with displaced distal radius fractures those who will receive surgical reduction and those who will not
Detailed Description:
Distal radius fractures are the most frequent fractures seen in pediatric population accounting for about 20-30 of all fractures in children for the non-displaced pediatric distal radius fractures it is agreed widely to be just managed by an immobilization cast in the emergency department However when it comes to the displaced fractures Different centers have different options of management mostly including either the surgical anatomical reduction under general anesthesia then casting with or without using other fixation method which is mostly k-wires or the other option includes only casting in the emergency department without trial of reduction or just a trial of realignment under sedating agent this second option depends on the unique phenomenon of remodeling in the pediatric fractures as Unlike adults in growing children remodeling can restore the alignment of the displaced fractures to a certain extent making anatomical reduction less essential specially when it comes to distal radius as The distal radial and ulnar physes are responsible for about 80 of forearm length and for 40 of upper limb length that making their remodeling potential can approach upto 100 depending on that the question was that if the fracture will be fully remodeled with no functional or range of motion disturbance on the conservative option so what the essentiality of the surgical option can be along with exposing the child to the dangers of general anesthesia the minor complications that can occur with k wires as neuropraxia pin tract infection or migration of the k wire emotional and financial load in a cost analysis for different options of treatment in displaced pediatric distal radius fractures the cost of surgical option exceeds the conservative one by multiple times According to that a lot of the current literature have suggested to consider conservative treatment of pediatric displaced distal radius fractures to be the gold standard and fundamental option of treatment In this study the investigators question the effectiveness of conservative treatment to displaced pediatric distal radius fractures casting in the emergency department in comparison to the surgical anatomical reduction in matters of functional and radiological parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None