Italian Version of the Oxford Elbow Score Score

NCT03727516 | Completed DMC

• 1 other identifier: 95/2018/Oss/AOUFe
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Elbow Disease; Patients Reported Outcomes; Elbow Surgery

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Minimal clinical change of the Italian version of the Oxford El bow Score

  Att 1month and 3 month post-surgery

Study Arms (1)

patients undergone elbow surgery

Patients undergone elbow surgery at routine follow up at 2 or 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Ability to speak and understand Italian,
• need for one-elbow surgical procedure any elbow disease.

You may not qualify if:

• Injury in more than one musculoskeletal district

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (2)

Ospedale Degli Infermi di Faenza

Faenza, Ravenna, 48018, Italy

Location

Azienda Ospedaliero-Universitaria Sant'Anna Cona

Ferrara, 44124, Italy

Location

Related Publications (6)

• 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. doi: 10.1002/art.22222.

  PMID: 17013824 RESULT

• 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.

  PMID: 23485685 RESULT

• 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.

  PMID: 18539627 RESULT

• 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.

  PMID: 12809562 RESULT

• 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.

  PMID: 18378921 RESULT

• 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.

  PMID: 28886018 RESULT

Study Officials

• Sara Padovani, M.D.

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

• Leo Massari

  Università degli Studi di Ferrara

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator, Orthopaedic Resident

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 1, 2018
• Study Start: July 24, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)