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

NCT ID: NCT06459557

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-04-01

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 .

Conditions

Fracture, Radius

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conservative treatment of displaced pediatric distal radius fractures

children in this group with displaced distal radius fractures would be managed by a cast in the emergency room without anatomically reducing the fracture under general anesthesia in the operating room

Group Type: ACTIVE_COMPARATOR

cast

Intervention Type: PROCEDURE

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

surgical reduction of displaced distal radius fractures

children in this group with displaced distal radius fractures would be managed by being anatomically reducing the fracture in the operating room under general anesthesia

Group Type: ACTIVE_COMPARATOR

surgical reduction

Intervention Type: PROCEDURE

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

Interventions

cast

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

Intervention Type: PROCEDURE

surgical reduction

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omar Hasan Mohamed

resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Omar Hasan, resident

Role: CONTACT

Omar.15235482@med.aun.edu.eg

01145422265

References

Akar D, Koroglu C, Erkus S, Turgut A, Kalenderer O. Conservative Follow-up of Severely Displaced Distal Radial Metaphyseal Fractures in Children. Cureus. 2018 Sep 5;10(9):e3259. doi: 10.7759/cureus.3259.

Reference Type: BACKGROUND

PMID: 30430048 (View on PubMed)

Shah AS, Guzek RH, Miller ML, Willey MC, Mahan ST, Bae DS; Pediatric Distal Radius Fracture (PDRF) Study Group. Descriptive Epidemiology of Isolated Distal Radius Fractures in Children: Results From a Prospective Multicenter Registry. J Pediatr Orthop. 2023 Jan 1;43(1):e1-e8. doi: 10.1097/BPO.0000000000002288. Epub 2022 Oct 26.

Reference Type: BACKGROUND

PMID: 36299238 (View on PubMed)

Hove LM, Brudvik C. Displaced paediatric fractures of the distal radius. Arch Orthop Trauma Surg. 2008 Jan;128(1):55-60. doi: 10.1007/s00402-007-0473-x. Epub 2007 Oct 17.

Reference Type: BACKGROUND

PMID: 17940779 (View on PubMed)

Sengab A, Krijnen P, Schipper IB. Displaced distal radius fractures in children, cast alone vs additional K-wire fixation: a meta-analysis. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1003-1011. doi: 10.1007/s00068-018-1011-y. Epub 2018 Oct 1.

Reference Type: BACKGROUND

PMID: 30276723 (View on PubMed)

Marinelli M, Massetti D, Facco G, Falcioni D, Coppa V, Maestri V, Gigante A. Remodeling of distal radius fractures in children: preliminary retrospective cost/analysis in level II pediatric trauma center. Acta Biomed. 2021 Nov 3;92(5):e2021390. doi: 10.23750/abm.v92i5.11971.

Reference Type: BACKGROUND

PMID: 34738560 (View on PubMed)

Naik P. Remodelling in Children's Fractures and Limits of Acceptability. Indian J Orthop. 2021 Mar 10;55(3):549-559. doi: 10.1007/s43465-020-00320-2. eCollection 2021 Jun.

Reference Type: BACKGROUND

PMID: 33995859 (View on PubMed)

Orland KJ, Boissonneault A, Schwartz AM, Goel R, Bruce RW Jr, Fletcher ND. Resource Utilization for Patients With Distal Radius Fractures in a Pediatric Emergency Department. JAMA Netw Open. 2020 Feb 5;3(2):e1921202. doi: 10.1001/jamanetworkopen.2019.21202.

Reference Type: BACKGROUND

PMID: 32058553 (View on PubMed)

Colovic H, Stankovic I, Dimitrijevic L, Zivkovic V, Nikolic D. The value of modified DASH questionnaire for evaluation of elbow function after supracondylar fractures in children. Vojnosanit Pregl. 2008 Jan;65(1):27-32. doi: 10.2298/vsp0801027c.

Reference Type: BACKGROUND

PMID: 18368935 (View on PubMed)

Other Identifiers

casting of distal radius

Identifier Type: -

Identifier Source: org_study_id