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Italian Version of the Oxford Elbow Score Score

Validation of the Cross-cultural Adapted Italian Version of the Oxford Elbow Score

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03727516
Acronym
Italian-OES
Enrollment
110
Registered
2018-11-01
Start date
2018-07-24
Completion date
2020-03-01
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elbow Disease, Elbow Surgery, Patients Reported Outcomes

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.

Interventions

None listed

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the Italian version of the Oxford Elbow Score (OES)up to 1 month post-surgeryThe 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)up to 1 month post-surgeryThis 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 Handup to 1 month post surgeryThe 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) Questionnaireup to 1 month post-surgeryThe 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).

Secondary

MeasureTime frameDescription
Minimal clinical change of the Italian version of the Oxford El bow ScoreAtt 1month and 3 month post-surgeryA group of patients will be interviewed at two different times points interval

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026