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Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction

Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction - a Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06459557
Enrollment
52
Registered
2024-06-14
Start date
2024-07-01
Completion date
2026-04-01
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture, Radius

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 .

Interventions

PROCEDUREcast

children with displaced distal radius fractures would be managed by a cast in the emergency room

PROCEDUREsurgical reduction

anatomical reduction of pediatric displaced distal radius fractures under general anesthesia in the operating room

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* All children aged 3 to 10 years * both genders * patients presenting with displaced distal radius fractures

Exclusion criteria

* intra articular fractures * Greenstick and buckle fractures * fractures with more than 1 week duration * non displaced fractures * Salter Harris fractures * open fractures * fractures with neurovascular bundle injury * poly trauma patients * patients with pathological bone diseases as Osteogenesis Imperfecta or CP (cerebral palsy) . * Galeazzi fractures

Design outcomes

Primary

MeasureTime frameDescription
mean difference of Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score between the two groups12 monthsfunctional assessment at 1.5 , 3 , 6 and 12 months posttrauma using the Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score as (50/50) (100%) is considered the maximum value which is the best outcome and (10/50) (0%) is considered the minimum value which is the worst outcome

Secondary

MeasureTime frameDescription
Comparing palmar tilt angle between the 2 groups .12 monthsradiological assessment poattraumatic at 1.5 , 3 , 6 ,12 months for lateral view of wrist joint for the 2 groups comparing palmar tilt angle which is the angle formed by a line drawn perpendicular to the axis of the radial shaft, and a line that passes through the tips of the dorsal and volar rims (i.e. along the radius articular surface)
Comparing radial inclination between the 2 groups12 monthsradiological assessment posttraumatic at 1.5 , 3 , 6 ,12 months for anterioposterior view of wrist joint for the 2 groups comparing radial inclination which is the angle between a line drawn perpendicular to the long axis of the radius along the articular surface of the distal radius and a line drawn down from the tip of the radial styloid
Comparing radius length between the 2 groups12 monthsradiological assessment posttraumatic at 1.5 , 3 , 6 ,12 months for anterioposterior view of wrist joint for the 2 groups comparing radius length which is the distance between two lines drawn perpendicular to the long axis of the radius on the AP projection from the apex of the radial styloid and level of the ulnar aspect of the articular surface

Contacts

Primary ContactOmar Hasan, resident
Omar.15235482@med.aun.edu.eg01145422265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026