Robert Jones Bandage Versus Cast in the Treatment of Distal Radius Fracture in Children

NCT05521464 | Completed DMC

• 1 other identifier: Jagar Omar
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Aim and objectives This study aimed to treat fractures of the distal end of the radius in the children with Robert Jones (RJ) bandage in comparison with a cast. The objective was to compare the frequency of occurrence of the complications, child comfortability, and family satisfaction with this treatment modality.

Conditions

Fracture Distal Radius; Children, Only

Keywords

Robert Jones bandage; cast

Outcome Measures

Primary Outcomes (1)

• Number of complications

  The complications were considered to be present if one of the following was noticed: 1. Skin problems like pressure soreness, skin irritation, itching, and dermatitis. 2. Bone deformity due to a displacement of the bone fragments at the fracture site to an unacceptable degree (tilt more than 15 degrees and/or shift more than 50% of the bone width at the fracture site) confirmed by the report of the radiologist, or due to growth disturbance from growth plate damage. 3. Joint stiffness by limitation of the wrist movements (limitation of more than 10 degrees in any direction). 4. Refracture within 12 weeks.

  6-12 weeks

Secondary Outcomes (2)

• Child comfortability with the treatment modality.

  6 weeks

• Family satisfaction the treatment modality.

  6-12 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Cast by Plaster of Paris

Other: cast

Group 2

EXPERIMENTAL

Robert Jones bandage

Other: Robert Jones Bandage

Interventions

cast OTHER

Application of a short arm cast from just below the elbow to the finger's knuckles. The cast was from a Plaster of Paris bandage over a cotton pad. The participants who received this treatment modality were considered group 1 (control group)

Also known as: Plaster of Paris

Group 1

Robert Jones Bandage OTHER

Modified RJ bandage (firmly applied two layers of bulky cotton layers alternating with two layers of elastic bandage in the following order: bandage - cotton - bandage - cotton - bandage). It was applied from below the elbow to the finger's knuckles. The participants who received this treatment modality were considered group 2 (trial group).

Also known as: Crepe bandages plus cotton rolls

Group 2

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: between 2-12 years old age.
• Sex: both male and female.
• Duration of symptoms: less than 5 days.
• Type of injury: fracture at the distal end of radius proofed by a radiograph film in two views (posteroanterior and lateral).
• Type of fracture: the fracture which is usually treated conservatively -without intervention- like:
• torus (buckle) metaphyseal fracture
• greenstick fracture
• undisplaced or minimal displaced fracture distal radial physis (Salter-Harris classification type 1 and 2 only) that does not need reduction
• undisplaced or minimal displaced metaphyseal fracture that doesn't need reduction (a tilt of fewer than 15 degrees and shift less than 5 millimeters at the fracture site in both views).

You may not qualify if:

• open fractures
• pathological fractures
• displaced fractures that need reduction
• delayed presentation beyond five days
• associated fracture of the ulnar bone
• polytraumatic cases.

Sponsors & Collaborators

• University of Duhok: lead

Study Sites (1)

Jagar Omar Doski

Duhok, Duhok Governorate / Kurdistan Region, 24001, Iraq

Location

Related Publications (5)

• Hedstrom EM, Svensson O, Bergstrom U, Michno P. Epidemiology of fractures in children and adolescents. Acta Orthop. 2010 Feb;81(1):148-53. doi: 10.3109/17453671003628780.

  PMID: 20175744 BACKGROUND

• Wilkins KE. Principles of fracture remodeling in children. Injury. 2005 Feb;36 Suppl 1:A3-11. doi: 10.1016/j.injury.2004.12.007.

  PMID: 15652934 BACKGROUND

• Al-Ansari K, Howard A, Seeto B, Yoo S, Zaki S, Boutis K. Minimally angulated pediatric wrist fractures: is immobilization without manipulation enough? CJEM. 2007 Jan;9(1):9-15. doi: 10.1017/s1481803500014676.

  PMID: 17391594 BACKGROUND

• Do TT, Strub WM, Foad SL, Mehlman CT, Crawford AH. Reduction versus remodeling in pediatric distal forearm fractures: a preliminary cost analysis. J Pediatr Orthop B. 2003 Mar;12(2):109-15. doi: 10.1097/01.bpb.0000043725.21564.7b.

  PMID: 12584495 BACKGROUND

• Edmonds EW. No difference in improvement in physical function between splint and cast at 6 weeks in children with minimally angulated fractures of the distal radius. Evid Based Med. 2011 Apr;16(2):49-50. doi: 10.1136/ebm1161. Epub 2010 Dec 7. No abstract available.

  PMID: 21139033 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

POLR1G protein, human; Calcium Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Minerals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jagar O Doski, Ph.D.

  College of Medicine, University of Duhok, Duhok, Iraq.

  PRINCIPAL INVESTIGATOR

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: Assistant Professor of orthopedics

Model Details: randomized controlled non-inferiority clinical trial of patients based on a parallel-group type with an allocation ratio of 1:1.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: October 1, 2021
• Primary Completion: August 20, 2022
• Study Completion: August 21, 2022
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: directly after publication of the article and whenever requested.
• Access Criteria: email: jagaromar@uod.ac

Locations

IR (1)