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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Shoulder

Treatments: Other: Questionnaire administration

Study type: Observational

Funder types: Other

Identifiers

NCT03790267

PaRIS-IOR

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4,260 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females aged 18-95 years
2. Be on the list for an elective primary arthroplasty of hip, knee or shoulder
3. Availability to sign the informed consent

Exclusion criteria

1. Severe cognitive impairment
2. To be listed for arthroplasty for musculoskeletal cancer
3. Not eligible for the surgical intervention

Trial design

4,260 participants in 3 patient groups

Hip arthroplasty

Treatment:

Other: Questionnaire administration

Knee arthroplasty

Treatment:

Other: Questionnaire administration

Shoulder arthroplasty

Treatment:

Other: Questionnaire administration