Italian Version of the Oxford Elbow Score Score

Elbow Disease Clinical Trial

— Italian-OES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727516
• Other study ID #: 95/2018/Oss/AOUFe
• Status: Completed
• Start date: July 24, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2020
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elbow Disease
• Elbow Surgery
• Patients Reported Outcomes

Locations

Country	Name	City	State
Italy	Ospedale Degli Infermi di Faenza	Faenza	Ravenna
Italy	Azienda Ospedaliero-Universitaria Sant'Anna Cona	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. Epub 2003 Jun — View 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, S — View 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. Review. — View Citation

Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Italian version of the Oxford Elbow Score (OES)	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.	up to 1 month post-surgery
Primary	The Mayo Elbow Performance Score (MEPS)	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).	up to 1 month post-surgery
Primary	Quick Disability of Arm Shoulder and Hand	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).	up to 1 month post surgery
Primary	The Short Form - 36 (SF-36) Questionnaire	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).	up to 1 month post-surgery
Secondary	Minimal clinical change of the Italian version of the Oxford El bow Score	A group of patients will be interviewed at two different times points interval	Att 1month and 3 month post-surgery