Robert Jones Bandage Versus Cast in the Treatment of Distal Radius Fracture in Children
NCT ID: NCT05521464
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
148 participants
INTERVENTIONAL
2021-10-01
2022-08-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Cast by Plaster of Paris
cast
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)
Group 2
Robert Jones bandage
Robert Jones Bandage
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cast
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)
Robert Jones Bandage
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 Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
1. torus (buckle) metaphyseal fracture
2. greenstick fracture
3. undisplaced or minimal displaced fracture distal radial physis (Salter-Harris classification type 1 and 2 only) that does not need reduction
4. 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).
Exclusion Criteria
* pathological fractures
* displaced fractures that need reduction
* delayed presentation beyond five days
* associated fracture of the ulnar bone
* polytraumatic cases.
2 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Duhok
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jagar Omar Doski
Assistant Professor of orthopedics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jagar O Doski, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
College of Medicine, University of Duhok, Duhok, Iraq.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jagar Omar Doski
Dihok, Duhok Governorate / Kurdistan Region, Iraq
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Wilkins KE. Principles of fracture remodeling in children. Injury. 2005 Feb;36 Suppl 1:A3-11. doi: 10.1016/j.injury.2004.12.007.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Jagar Omar
Identifier Type: -
Identifier Source: org_study_id