Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06343857 |
| Other study ID # |
CE-AVEC 878/2022/Oss/AOUFe |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University Hospital of Ferrara |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The present study represents the pilot phase of the project aimed at developing anatomical
site-specific self-assessment questionnaires (shoulder, knee and ankle) that can advise the
subject of the need for an orthopaedic specialist examination.
The pilot phase of the project involves the collection of data from questionnaires in a
population of subjects who have requested an orthopaedic consultation for the anatomical site
covered by the questionnaire. Each questionnaire consists of questions designed to collect
information about the patient's subjective condition.
The data collected from the questionnaires will be used to evaluate the statistical
significance (p value) of each question in the questionnaire in relation to the outcome of
the orthopaedic specialist visit. Through a multivariate logistic analysis of the answers
given by the subject, it will be possible to 'weight' each answer to obtain a final value
that gives an indication of an orthopaedic specialist visit.
Description:
With the present study, an initial exploratory phase is conducted aimed at developing
anatomical site-specific self-assessment questionnaires (shoulder, knee, and ankle) capable
of directing the subject to the need for an orthopedic specialist visit. The questionnaire
will allow the subject to understand whether his or her symptomatology indicates the presence
of a clinical condition requiring orthopedic specialist examination. In this way, it will be
possible to identify patients in need of a specialist visit in a timely manner, avoiding
chronicity of the painful symptomatology and allowing early diagnosis and potentially faster
functional recovery.
To this end, starting from the analysis of clinically validated 1-10 questionnaires,
orthopedic specialists afferent to the University of Ferrara, the Rizzoli Orthopedic
Institute, and the Galeazzi Orthopedic Institute collaboratively developed questionnaires
with the following characteristics:
1. Subjectivity: the questions in the questionnaires require an answer that reflects a
specific condition of the subject, e.g. ability to carry out daily or sporting
activities.
2. Specificity: the questions in the questionnaires are specific to the anatomical district
(shoulder, knee, ankle).
3. Simplicity: being a questionnaire completed by the subject in complete autonomy, the
questions are written in simple language and the compilation method is intuitive.
4. Reliability: the score obtained from completing the questionnaires must be able to
distinguish subjects who require further diagnostic tests from subjects who require
pharmacological therapy, physical therapy, or no therapy.
The self-assessment forms are provided as an attachment to the clinical protocol.
The present study represents the pilot phase of the project aimed at developing
self-assessment questionnaires specific to anatomical site (shoulder, knee, and ankle) and
involves the collection of data from self-assessment forms in a population of subjects who
have requested an orthopedic specialist visit for the anatomical site covered by the
questionnaire. As part of the proposed study, the answers provided by the patient will be
compared with the outcome of the orthopedic specialist visit.
The data collected from the questionnaires will be used to: 1. evaluate the statistical
significance (p value) of each question in the questionnaire in relation to the result of the
orthopedic specialist visit. and 2. assign a score to each response in relation to the
outcome of the orthopedic specialist visit.
The proposed study will allow us to develop self-assessment questionnaires which, based on
simple questions, can direct the patient towards the need for an orthopedic specialist visit.
