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

NCT06459557 | Not Yet Recruiting

• 1 other identifier: casting of distal radius
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fracture, Radius

Outcome Measures

Primary Outcomes (1)

• mean difference of Modifed the Disabilities of the Arm, Shoulder and Hand (m-DASH) score between the two groups

  functional 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

  12 months

Secondary Outcomes (3)

• Comparing palmar tilt angle between the 2 groups .

  12 months

• Comparing radial inclination between the 2 groups

  12 months

• Comparing radius length between the 2 groups

  12 months

Study Arms (2)

conservative treatment of displaced pediatric distal radius fractures

ACTIVE COMPARATOR

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

Procedure: cast

surgical reduction of displaced distal radius fractures

ACTIVE COMPARATOR

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

Procedure: surgical reduction

Interventions

cast PROCEDURE

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

conservative treatment of displaced pediatric distal radius fractures

surgical reduction PROCEDURE

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

surgical reduction of displaced distal radius fractures

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 30430048 BACKGROUND

• 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.

  PMID: 36299238 BACKGROUND

• 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.

  PMID: 17940779 BACKGROUND

• 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.

  PMID: 30276723 BACKGROUND

• 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.

  PMID: 34738560 BACKGROUND

• 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.

  PMID: 33995859 BACKGROUND

• 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.

  PMID: 32058553 BACKGROUND

• 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.

  PMID: 18368935 BACKGROUND

MeSH Terms

Conditions

Radius Fractures

Interventions

POLR1G protein, human

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Omar Hasan, resident

CONTACT

01145422265; Omar.15235482@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: June 14, 2024
• Study Start: July 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06