Validation of the Cross-cultural Adapted Italian Version of the Oxford Elbow Score
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Quick Disability of Arm Shoulder and Hand
研究概览
简要总结
Validation of the cross-cultural adapted Italian version of the Oxford Elbow Score, in order to have an instrument able to detect the functional state reported by patients after elbow surgery.
详细描述
An Italian version of the Oxford Elbow Score has been created by an experts committee, according to the published guidelines for the cross-cultural adaptation of self-reported measures.
The new version of the questionnaire will be administered to a sample size of 120 patients, in addition to MEPS, Quick DASH and SF-36 questionnaires during the follow-up apointments at 2 and/or 6 months after elbow surgery in two Orthopaedic Clinic in North Italy.
Reliability, validity , reproducibility and responsiveness will be detected by questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to speak and understand Italian,
- •need for one-elbow surgical procedure any elbow disease.
排除标准
- •Injury in more than one musculoskeletal district
结局指标
主要结局
Quick Disability of Arm Shoulder and Hand
时间窗: up to 1 month post surgery
The Quick DASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5).
the Italian version of the Oxford Elbow Score (OES)
时间窗: up to 1 month post-surgery
The Oxford Elbow Score (OES) is a disease-specific questionnaire, completed by patients, which assesses: pain, function and psychological status related to the elbow joint. Each domain is transformed into a 100-point score, where the highest value indicates a better condition. The total score is the result of the average of the three domains.
The Short Form - 36 (SF-36) Questionnaire
时间窗: up to 1 month post-surgery
The Sort Form-36 is widely used questionnaire to survey health related quality of life. The questionnaire is a 36-items that measures eight domains of health reporting a score from 0 (worst) to 100 (best).
The Mayo Elbow Performance Score (MEPS)
时间窗: up to 1 month post-surgery
This questionnaire evaluates pain, range of motion, joint stability and the ability to perform 5 movements, respectively. The function of the elbow is considered excellent (score ≥ 90), good (75-89), modest (60-74), and poor (\<60).
次要结局
- Minimal clinical change of the Italian version of the Oxford El bow Score(Att 1month and 3 month post-surgery)
研究者
Sara Padovani
Medical Doctor, Principal Investigator, Orthopaedic Resident
Università degli Studi di Ferrara