Elbow DiseaseItalian-OESNCT03727516
Italian Version of the Oxford Elbow Score Score
An observational study of Elbow Disease and Patients Reported Outcomes, run by Università degli Studi di Ferrara at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Disease, Patients Reported Outcomes, Elbow Surgery
- How many people
- 110 participants
- Where
- 2 sitesItaly
- Study dates
- 24 Jul 2018to 1 Mar 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Ability to speak and understand Italian,
- need for one-elbow surgical procedure any elbow disease.
Who cannot join
- Injury in more than one musculoskeletal district
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ospedale Degli Infermi di Faenza
Faenza, Ravenna, 48018
Azienda Ospedaliero-Universitaria Sant'Anna Cona
Ferrara, 44124
About this study
Official title: Validation of the Cross-cultural Adapted Italian Version of the Oxford Elbow Score
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.
Read the 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.
- Conditions
- Elbow Disease, Patients Reported Outcomes, Elbow Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients undergone elbow surgery | Patients undergone elbow surgery at routine follow up at 2 or 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: up to 1 month post-surgery
Secondary outcomes (1)
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
Measured: Att 1month and 3 month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start24 Jul 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Elbow DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Padovani, Università degli Studi di Ferrara
- Investigators
- Sara Padovani, M.D., Principal investigator, Università degli Studi di FerraraLeo Massari, Study chair, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727516
- Sponsor's protocol ID
- 95/2018/Oss/AOUFe
- Acronym
- Italian-OES
- Status last verified
- Jun 2020
- First submitted
- 22 Oct 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17013824Vincent 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.
PubMed 23485685Longo 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.
PubMed 18539627Gummesson 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.
PubMed 12809562Dawson 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.
PubMed 18378921Iordens 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.
PubMed 28886018
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Cross-cultural Adapted Italian Version of the Oxford Elbow Score
- ClinicalTrials.gov ID
- NCT03727516
- Acronym / sponsor ID
- Italian-OES / 95/2018/Oss/AOUFe
- Conditions
- Elbow Disease, Patients Reported Outcomes, Elbow Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergone elbow surgery | – | –Patients undergone elbow surgery at routine follow up at 2 or 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Ability to speak and understand Italian,
- need for one-elbow surgical procedure any elbow disease.
Key exclusion criteria (1 listed)
- Injury in more than one musculoskeletal district
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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).
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).
1 secondary outcome
Minimal clinical change of the Italian version of the Oxford El bow Score
Time frame: Att 1month and 3 month post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Results publication: PubMed 17013824Roquelaure 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.
- Results publication: PubMed 23485685Vincent 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.
- Results publication: PubMed 18539627Longo 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.
- Results publication: PubMed 12809562Gummesson 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.
- Results publication: PubMed 18378921Dawson 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.
- Results publication: PubMed 28886018Iordens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Padovani, M.D. principal investigator
Università degli Studi di Ferrara
Leo Massari study chair
Università degli Studi di Ferrara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Disease and Patients Reported Outcomes, run by Università degli Studi di Ferrara at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Italian version of the Oxford Elbow Score (OES) (time frame: up to 1 month post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727516, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.