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Completed

NCT Number: NCT03727516

Italian Version of the Oxford Elbow Score Score

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.

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Key information

Conditions

Elbow Disease Elbow Surgery Patients Reported Outcomes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Degli Infermi di Faenza, Faenza, Ravenna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

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

Acronym: Italian-OES

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2018
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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