Italian Version of the Oxford Elbow Score Score (Italian-OES)
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|ClinicalTrials.gov Identifier: NCT03727516|
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : April 16, 2019
|Condition or disease|
|Elbow Disease Patients Reported Outcomes Elbow Surgery|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Validation of the Cross-cultural Adapted Italian Version of the Oxford Elbow Score|
|Actual Study Start Date :||July 24, 2018|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||December 23, 2020|
patients undergone elbow surgery
Patients undergone elbow surgery at routine follow up at 2 or 6 months
- the Italian version of the Oxford Elbow Score (OES) [ Time Frame: 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 Mayo Elbow Performance Score (MEPS) [ Time Frame: 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).
- Quick Disability of Arm Shoulder and Hand [ Time Frame: 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 Short Form - 36 (SF-36) Questionnaire [ Time Frame: 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).
- Minimal clinical change of the Italian version of the Oxford El bow Score [ Time Frame: Att 1month and 3 month post-surgery ]A group of patients will be interviewed at two different times points interval
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727516
|Contact: Sara Padovani, M.D.||+39 firstname.lastname@example.org|
|Contact: Leo Massari, M.D.||+email@example.com|
|Ospedale Degli Infermi di Faenza||Recruiting|
|Faenza, Ravenna, Italy, 48018|
|Contact: Alessandra Colozza, MD|
|Principal Investigator: Sara Padovani, MD|
|Principal Investigator: Alessandra Colozza, MD|
|Sub-Investigator: Maurizio Fontana, MD|
|Azienda Ospedaliero-Universitaria Sant'Anna Cona||Recruiting|
|Ferrara, Italy, 44124|
|Contact: Sara Padovani +39 3474733961 firstname.lastname@example.org|
|Principal Investigator: Sara Padovani, M.D.|
|Principal Investigator: Gaetano Caruso, MD|
|Principal Investigator: Leo Massari, MD|
|Principal Investigator:||Sara Padovani, M.D.||Università degli Studi di Ferrara|
|Study Chair:||Leo Massari||Università degli Studi di Ferrara|