OsteoarthritisNCT06343857
Joint Self-Assessment Forms for Knee, Ankle and Shoulder
An observational study of Osteoarthritis, run by University Hospital of Ferrara at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- self-assessment questionnaire
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 1 May 2023to 30 Apr 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatients, orthopaedic clinic
Who may be able to join
- Subjects who have requested an orthopaedic specialist examination for the anatomical site covered by the self-assessment form;
- Age 18 years or older;
- Comprehension of the Italian language.
Who cannot join
- Surgery within the previous 12 months at the anatomical site covered by the self-assessment form.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica II
Bologna, BO
Unità Operativa di Chirurgia della Spalla I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy
About this study
Official title: Spontaneous Multicenter Prospective Observational Study for the Development of Joint Wellness Self-assessment Forms
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.
Read the detailed 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:
- 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.
- Specificity: the questions in the questionnaires are specific to the anatomical district (shoulder, knee, ankle).
- Simplicity: being a questionnaire completed by the subject in complete autonomy, the questions are written in simple language and the compilation method is intuitive.
- 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.
- Conditions
- Osteoarthritis
- Being tested
- self-assessment questionnaire
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-assessment questionnaireDiagnostic test
Completion of the anatomical site-specific self-assessment questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Anatomical site | Subjects who have requested an orthopaedic specialist examination for the knee, or ankle or shoulder Receives: Diagnostic Test: self-assessment questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of the distribution of questionnaire responses for each anatomical site.
The data collected from the questionnaires will be used to assess the statistical significance (p value) of each question in the questionnaire in relation to the outcome of the orthopedic specialist examination
Measured: baseline
Secondary outcomes (1)
Therapeutic indication of the orthopaedic specialist for each subject participating in the study
The collection of the orthopaedic specialist's opinion on the therapeutic indication for each subject participating in the study.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 May 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leo Massari, University Hospital of Ferrara
- Investigators
- Leo Massari, MD, Principal investigator, Azienda Ospedaliera-Universitaria Arcispedale S. Anna di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343857
- Sponsor's protocol ID
- CE-AVEC 878/2022/Oss/AOUFe
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Multicenter Prospective Observational Study for the Development of Joint Wellness Self-assessment Forms
- ClinicalTrials.gov ID
- NCT06343857
- Acronym / sponsor ID
- CE-AVEC 878/2022/Oss/AOUFe
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 3 Apr 2024 (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.
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.
Detailed 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:
- 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.
- Specificity: the questions in the questionnaires are specific to the anatomical district (shoulder, knee, ankle).
- Simplicity: being a questionnaire completed by the subject in complete autonomy, the questions are written in simple language and the compilation method is intuitive.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anatomical site | – | Diagnostic Test: self-assessment questionnaireSubjects who have requested an orthopaedic specialist examination for the knee, or ankle or shoulder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients, orthopaedic clinic
Key inclusion criteria (3 listed)
- Subjects who have requested an orthopaedic specialist examination for the anatomical site covered by the self-assessment form;
- Age 18 years or older;
- Comprehension of the Italian language.
Key exclusion criteria (1 listed)
- Surgery within the previous 12 months at the anatomical site covered by the self-assessment form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-assessment questionnaireCompletion of the anatomical site-specific self-assessment questionnaire. | Diagnostic test | Anatomical site |
Primary outcome
Observation of the distribution of questionnaire responses for each anatomical site.
Time frame: baseline
The data collected from the questionnaires will be used to assess the statistical significance (p value) of each question in the questionnaire in relation to the outcome of the orthopedic specialist examination
1 secondary outcome
Therapeutic indication of the orthopaedic specialist for each subject participating in the study
Time frame: baseline
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 1 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
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.
Leo Massari, MD principal investigator
Azienda Ospedaliera-Universitaria Arcispedale S. Anna 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 Osteoarthritis, run by University Hospital of 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 3 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 1 May 2026. 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?
Observation of the distribution of questionnaire responses for each anatomical site. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.