Clinical trial NCT03727516: Italian Version of the Oxford Elbow Score Score
Official title: Validation of the Cross-cultural Adapted Italian Version of the Oxford Elbow Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elbow Disease
Patients Reported Outcomes
Elbow Surgery
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: the Italian version of the Oxford Elbow Score (OES)
timeFrame: up to 1 month post-surgery
measure: The Mayo Elbow Performance Score (MEPS)
timeFrame: up to 1 month post-surgery
measure: Quick Disability of Arm Shoulder and Hand
timeFrame: up to 1 month post surgery
measure: The Short Form - 36 (SF-36) Questionnaire
timeFrame: up to 1 month post-surgery
Secondary outcomes:
measure: Minimal clinical change of the Italian version of the Oxford El bow Score
timeFrame: Att 1month and 3 month post-surgery
Other outcomes:
Locations:
city: Faenza
country: Italy
facility: Ospedale Degli Infermi di Faenza
state: Ravenna
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Anna Cona
Study officials:
affiliation: Università degli Studi di Ferrara
name: Sara Padovani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Ferrara
name: Leo Massari
role: STUDY_CHAIR
References:
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citation: Vincent JI, MacDermid JC, King GJ, Grewal R. Validity and sensitivity to change of patient-reported pain and disability measures for elbow pathologies. J Orthop Sports Phys Ther. 2013 Apr;43(4):263-74. doi: 10.2519/jospt.2013.4029. Epub 2013 Mar 13.
citation: Longo UG, Franceschi F, Loppini M, Maffulli N, Denaro V. Rating systems for evaluation of the elbow. Br Med Bull. 2008;87:131-61. doi: 10.1093/bmb/ldn023. Epub 2008 Jun 6.
citation: Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
citation: Dawson J, Doll H, Boller I, Fitzpatrick R, Little C, Rees J, Jenkinson C, Carr AJ. The development and validation of a patient-reported questionnaire to assess outcomes of elbow surgery. J Bone Joint Surg Br. 2008 Apr;90(4):466-73. doi: 10.1302/0301-620X.90B4.20290.
citation: Iordens GIT, Den Hartog D, Tuinebreijer WE, Eygendaal D, Schep NWL, Verhofstad MHJ, Van Lieshout EMM; FuncSiE Trial Investigators. Minimal important change and other measurement properties of the Oxford Elbow Score and the Quick Disabilities of the Arm, Shoulder, and Hand in patients with a simple elbow dislocation; validation study alongside the multicenter FuncSiE trial. PLoS One. 2017 Sep 8;12(9):e0182557. doi: 10.1371/journal.pone.0182557. eCollection 2017.