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NCT04960098 Clinical Trial

Patient-reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:
Patient-Reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty in Galeazzi Orthopaedic Institute Milano

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04960098
Other study ID # PROMS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 12, 2016
Est. completion date December 31, 2050

Study information
Verified date July 2021
Source Istituto Ortopedico Galeazzi
Contact Michele Ulivi
Phone 00390266214946
Email micheleulivi@masn.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Registry of Galeazzi Orthopedic Institute: provides for the regular and systematic collection of all data (clinical and some PROMs) obtained from patients undergoing hip and knee arthroplasty to which questionnaires are proposed investigating the specific functional sphere of the joints undergoing surgery (Knee injuryOsteoarthritisOutcomeScore (KOOS-PS) and Hip injuryOsteoarthritisOutcomeScore (HOOS-PS) but also the sphere of general health (ShortForm health survey-12 (SF-12) and VisualAnalogueScale (VAS)) , in addition, of course, to the satisfaction rate.

Recruitment information / eligibility
Status Recruiting
Enrollment 5816
Est. completion date December 31, 2050
Est. primary completion date December 31, 2050
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - male and female - age more than 18 - patient underwent hip or knee arthroplasty Exclusion Criteria: - age less than 18 - comorbidity that can results in the difficulty to come back for the follow up

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• arthroplasty
patient with hip and knee osteoarthritis underwent hip and knee arthroplasty

Locations
Country Name City State
Italy Istituto Ortopedico Galeazzi Milano

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary outcome measurements improve evaluation of hip and knee arthroplasty monitoring patient reported outcome measurements before and after surgery. pre operative to 10 years
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