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Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty — PaRIS-IOR  

Arthroplasty, Replacement, Knee Clinical Trial

Official title:
Functional Outcomes and Quality of Life Reported by Adult Patients Undergoing Elective Hip, Knee and Shoulder Arthroplasty

Clinical Trial Summary

PaRIS-IOR is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR).

Clinical Trial Description

PaRIS-IOR is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR). IOR was selected as a pilot center for the launch of the OECD's PaRIS Initiative in Italy, whose purpose is to accelerate the adoption and reporting of validated, standardised, internationally-comparable patient-reported indicators, particularly within patient registries. PaRIS-IOR's study population will consist of consecutive patients undergoing hip, knee and shoulder arthroplasty performed at 6 Operative Units of the IOR. The study will last 30 months and will include a 12-month recruitment period, a 12-month follow-up and 6 months for data analysis and reporting. Functional outcomes and quality of life will be detected through the administration of validated questionnaires (EQ-5D, HOOS, KOOS, ASES). The questionnaires will be administered in the month preceding the surgical procedure in the clinic or in the ward, while the 2 follow-up questionnaires will be send by mail at patients' home. The collected data will be combined with those routinely collected by the Registry of Orthopedic Prosthetic Implantology (RIPO), already active at the IOR since year 1990. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03790267
Study type Observational
Source Istituto Ortopedico Rizzoli
Contact
Status Completed
Phase
Start date January 1, 2019
Completion date December 31, 2023
View Details
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