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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
Sponsor:
Information provided by (Responsible Party):
Sara Padovani, 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.

Condition or disease
Elbow Disease Patients Reported Outcomes 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
patients undergone elbow surgery
Patients undergone elbow surgery at routine follow up at 2 or 6 months



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
It is required a sample of 120 consecutive patients interviewed at routine follow up visit at 2 and/or 6 month after elbow surgery.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Sara Padovani, M.D. +39 3474733961 pdvsra@unife.it
Contact: Leo Massari, M.D. +390532236891 msl@unife.it

Locations
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Italy
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    pdvsra@unife.it   
Principal Investigator: Sara Padovani, M.D.         
Principal Investigator: Gaetano Caruso, MD         
Principal Investigator: Leo Massari, MD         
Sponsors and Collaborators
Università degli Studi di Ferrara
Investigators
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Principal Investigator: Sara Padovani, M.D. Università degli Studi di Ferrara
Study Chair: Leo Massari Università degli Studi di Ferrara

Additional Information:

Publications of Results:

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Responsible Party: Sara Padovani, Medical Doctor, Principal Investigator, Orthopaedic Resident, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT03727516     History of Changes
Other Study ID Numbers: 95/2018/Oss/AOUFe
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No