Robert Jones Bandage Versus Cast in the Treatment of Distal Radius Fracture in Children
Condition: Fracture Distal Radius; Children, Only
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

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.
    

Detailed description: 
      Methods Study type and approvals The study was a randomized controlled non-inferiority
      clinical trial of patients based on a parallel-group type with an allocation ratio of 1:1.

      Sittings The study was done in the emergency reception unit and the orthopedic unit of Duhok
      Emergency Teaching Hospital (single-center study), Duhok city, Iraq during the period
      extending from October 2021 to August 2022.

      The study was conducted by a team from the hospital composed of a consultant Orthopedic
      surgeon (person 1), a permanent resident orthopedic doctor (person 2), and a radiologist
      (person 3). Person 1 generates the random allocation sequence, assessed the outcome
      clinically, analyzed the results, and drafted the article. Person 2 enrolled the participants
      in the study, assigned the interventions, and drafted the article. Person 3 assessed the
      outcome radiologically.

      Interventions The participants included received one of the modalities of treatment planned
      for this study. The first modality was by 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 received this modality of treatment considered as group 1 (control
      group). The second modality was the modified RJ bandage (firmly applied two layers of bulky
      cotton layers alternating with three layers of elastic bandage in the following order:
      bandage - cotton - bandage - cotton - bandage)[17]. It was applied from below the elbow to
      the finger's knuckles. The participants received this modality of treatment considered as
      group 2 (trial group).

      The participants and their companions were instructed to keep their modality of treatment
      clean and dry. Both groups asked for frequent follow-up (at the end of the 2nd, 4th, 6th, and
      12th week) until the fracture unit. At each follow-up visit, the participant was checked for
      possible complications. The final assessment was done at the end of the 12th week by the
      consultant orthopedic doctor in collaboration with the radiologist.

      Sample size calculation The assumed sample size was calculated by using the G*Power 3.1.9.7
      computer software program. A minimum of 148 participants (74 for each group) was required to
      have a power of 80% chance of detecting the difference between the groups, and a two-sided
      95% level of confidence (0.05 level of significance) to avoid the type 1 -alpha- error, with
      a probable hypothetical effect size of about 0.3 and a degree of freedom of 1 in the
      contiguity table.

      Randomization The allocation of the participants into the modalities of the treatment was
      done by a simple randomization method with an allocation ratio of 1:1. It was generated by
      using the website program www.randomization.com. The first generator of the program was used
      to randomize 148 subjects into both modalities of treatment blocks (74 casts, 74 RJ bandages)
      (seed 7180). The random allocation sequence was generated by person 1 from the team of the
      study. It was concealed from the rest of the study team. Person 2 enrolled the participants
      in the study (assessed the eligibility of the cases, obtained the informed consent) and
      assigned the interventions.

      Blinding The team of the study (apart from person 3 - the radiologist) was not blinded to the
      modality of treatment that they provided to the patients. The radiologist who assessed the
      radiological outcome of the cases was blinded to the modalities of treatment. The
      participants were blinded to the result of the treatment of the other patients included in
      this study.

      The data collection

      The data was collected in a special paper for each patient separately. The data included were
      divided into two parts:

      Part 1 included the basic demographic data of the patient and injury like name, age, gender,
      place of living, date of a wrist injury, type of wrist injury (proved by the radiographic
      film), type of treatment (group), the time interval between the injury and beginning of
      treatment, duration of treatment, dates of each follow up. Part 2 included the outcomes
      during each follow-up visit and at the final assessment like complications of treatment,
      patient comfortability, and family satisfaction.

      Statistical analysis The data analysis was done by admitting the collected data into the
      Statistical Package for Social Sciences (SPSS) software computer program (IBM Corp. Released
      2015. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp.). The statistical
      analysis included the standard descriptive statistics used to describe the basic descriptive
      data of the patients and injuries. The means and standard deviations (SD) or medians and
      interquartile ranges were used for the continuous variables, while frequencies and
      percentages were used for the categorical variables. The comparison between the outcomes of
      the treatment modalities in both groups was done by finding the difference between the
      summary statistics in the chi-squared test. The difference was considered statistically
      significant when the p-value was less than 0.05.
    

Intervention name(s): cast; Robert Jones Bandage
Intervention type(s): Other; Other
Intervention description(s): 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); 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).
Other intervention name(s): Plaster of Paris; Crepe bandages plus cotton rolls
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled non-inferiority clinical trial of patients based on a parallel-group type with an allocation ratio of 1:1.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Robert Jones bandage; cast