Robert Jones Bandage Versus Cast in the Treatment of Distal Radius Fracture in Children: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Number of complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •open fractures
- •pathological fractures
- •displaced fractures that need reduction
- •delayed presentation beyond five days
- •associated fracture of the ulnar bone
- •polytraumatic cases.
结局指标
主要结局
Number of complications
时间窗: 6-12 weeks
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.
次要结局
- Family satisfaction the treatment modality.(6-12 weeks)
- Child comfortability with the treatment modality.(6 weeks)
研究者
Jagar Omar Doski
Assistant Professor of orthopedics
University of Duhok