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

Arthroplasty, Replacement, Knee Clinical Trial

— PaRIS-IOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790267
• Other study ID #: PaRIS-IOR
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4260
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee
• Arthroplasty, Replacement, Shoulder

Intervention

Other:
• Questionnaire administration
One questionnaire (Euro Quality 5 Dimensions, EQ-5D) for the general assessment of patient's health status will be administered to all the patients in the study. One joint-specific questionnaires will be administered to patients depending on the surgery procedure they will be undergoing. Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement (6); Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement (7); the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcomes: total score of the joint-specific functional scales.	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).	Baseline
Primary	Functional outcomes: total score of the joint-specific functional scales.	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).	6 months after surgery
Primary	Functional outcomes: total score of the joint-specific functional scales.	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).	12 months after surgery
Primary	Euro-Quality-5-Dimensions questionnaire scores.	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).	Baseline
Primary	Euro-Quality-5-Dimensions questionnaire scores.	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).	6 months after surgery
Primary	Euro-Quality-5-Dimensions questionnaire scores.	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).	12 months after surgery
Primary	Visual analogue scale (EQ-VAS) scores	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".	Baseline
Primary	Visual analogue scale (EQ-VAS) scores	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".	6 months after surgery
Primary	Visual analogue scale (EQ-VAS) scores	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".	12 months after surgery