Joint Self-Assessment Forms for Knee, Ankle and Shoulder

NCT06343857 | Completed

• 1 other identifier: CE-AVEC 878/2022/Oss/AOUFe
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Secondary Outcomes (1)

• Therapeutic indication of the orthopaedic specialist for each subject participating in the study

  baseline

Study Arms (1)

Anatomical site

Subjects who have requested an orthopaedic specialist examination for the knee, or ankle or shoulder

Diagnostic Test: self-assessment questionnaire

Interventions

self-assessment questionnaire DIAGNOSTIC_TEST

Completion of the anatomical site-specific self-assessment questionnaire.

Anatomical site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

outpatients, orthopaedic clinic

You may qualify if:

• 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.

You may not qualify if:

• Surgery within the previous 12 months at the anatomical site covered by the self-assessment form.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (2)

IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica II

Bologna, BO, Italy

Location

Unità Operativa di Chirurgia della Spalla I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy, Italy

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Leo Massari, MD

  Azienda Ospedaliera-Universitaria Arcispedale S. Anna di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 3, 2024
• Study Start: May 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 1, 2026

Record last verified: 2024-03

Locations

IT (2)