Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty

Completed

• Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Shoulder
• Interventions: Other: Questionnaire administration

• Registration Number: NCT03790267
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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).

Detailed 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 Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Study Start: 2019-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shoulder arthroplasty	Questionnaire administration	-
Hip arthroplasty	Questionnaire administration	-
Knee arthroplasty	Questionnaire administration	-

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (EQ-VAS) scores	12 months after surgery	The respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100: (0) corresponds to " the worst health you can imagine", and (100) corresponds to "the best health you can imagine".
Functional outcomes: total score of the joint-specific functional scales.	12 months after surgery	The joint-specific functional scales derive from the following validated questionnaires: Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement; Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement; the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants. For all questionnaires the items are coded from 0 to 4, no functional difficulty to extreme functional difficulty respectively. The total score of the questionnaires can go from 0 (worst outcome) to 100 (best outcome).
Euro-Quality-5-Dimensions questionnaire scores.	12 months after surgery	Euro Quality 5 Dimensions, EQ-5D, will be used for the general assessment of patient's health status. The EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents are asked to choose one of the statements which best describes their health status of surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy