Italian Version of the Oxford Elbow Score Score

Completed

• Conditions: Patients Reported Outcomes; Elbow Disease; Elbow Surgery

• Registration Number: NCT03727516
• Lead Sponsor: Università degli Studi di Ferrara

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-07-24
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-12
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Ability to speak and understand Italian,
• need for one-elbow surgical procedure any elbow disease.

Exclusion Criteria

• Injury in more than one musculoskeletal district

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quick Disability of Arm Shoulder and Hand	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)	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	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)	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).

Secondary Outcome Measures

Name	Time	Method
Minimal clinical change of the Italian version of the Oxford El bow Score	Att 1month and 3 month post-surgery	A group of patients will be interviewed at two different times points interval

Trial Locations

Locations (2)

Ospedale Degli Infermi di Faenza; 🇮🇹 Faenza, Ravenna, Italy

Azienda Ospedaliero-Universitaria Sant'Anna Cona; 🇮🇹 Ferrara, Italy