Clinical Trial on Patients Reported Outcomes, Elbow Disease, Elbow Surgery - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Ferrara, Italy, 44124
    - Azienda Ospedaliero-Universitaria Sant'Anna Cona
- Ravenna
  - Faenza, Ravenna, Italy, 48018
    - Ospedale Degli Infermi di Faenza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 1 month post-surgery
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).	up to 1 month post-surgery
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).	up to 1 month post surgery
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).	up to 1 month post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Att 1month and 3 month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Investigators

Principal Investigator: Sara Padovani, M.D., Università degli Studi di Ferrara
Study Chair: Leo Massari, Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 24, 2018

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (ACTUAL)

November 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

95/2018/Oss/AOUFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Italian Version of the Oxford Elbow Score Score (Italian-OES)

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