- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790267
Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty (PaRIS-IOR)
Functional Outcomes and Quality of Life Reported by Adult Patients Undergoing Elective Hip, Knee and Shoulder Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Stefano Zaffagnini, MD
- Phone Number: +39 0516366520
- Email: stefano.zaffagnini@unibo.it
Study Contact Backup
- Name: Susanna Stea, PhD
- Email: susanna.stea@ior.it
Study Locations
-
-
-
Bologna, Italy, 40136
- Istituto Ortopedico Rizzoli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males and females aged 18-95 years
- Be on the list for an elective primary arthroplasty of hip, knee or shoulder
- Availability to sign the informed consent
Exclusion Criteria:
- Severe cognitive impairment
- To be listed for arthroplasty for musculoskeletal cancer
- Not eligible for the surgical intervention
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hip arthroplasty
|
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.
|
Knee arthroplasty
|
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.
|
Shoulder arthroplasty
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional outcomes: total score of the joint-specific functional scales.
Time Frame: Baseline
|
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
|
Functional outcomes: total score of the joint-specific functional scales.
Time Frame: 6 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).
|
6 months after surgery
|
Functional outcomes: total score of the joint-specific functional scales.
Time Frame: 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).
|
12 months after surgery
|
Euro-Quality-5-Dimensions questionnaire scores.
Time Frame: Baseline
|
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
|
Euro-Quality-5-Dimensions questionnaire scores.
Time Frame: 6 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).
|
6 months after surgery
|
Euro-Quality-5-Dimensions questionnaire scores.
Time Frame: 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).
|
12 months after surgery
|
Visual analogue scale (EQ-VAS) scores
Time Frame: Baseline
|
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
|
Visual analogue scale (EQ-VAS) scores
Time Frame: 6 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".
|
6 months after surgery
|
Visual analogue scale (EQ-VAS) scores
Time Frame: 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".
|
12 months after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Golinelli D, Grassi A, Tedesco D, Sanmarchi F, Rosa S, Rucci P, Amabile M, Cosentino M, Bordini B, Fantini MP, Zaffagnini S. Patient reported outcomes measures (PROMs) trajectories after elective hip arthroplasty: a latent class and growth mixture analysis. J Patient Rep Outcomes. 2022 Sep 9;6(1):95. doi: 10.1186/s41687-022-00503-5.
- Grassi A, Golinelli D, Tedesco D, Rolli M, Bordini B, Amabile M, Rucci P, Fantini MP, Zaffagnini S. Patient-reported outcome measures (PROMs) after elective hip, knee and shoulder arthroplasty: protocol for a prospective cohort study. BMC Musculoskelet Disord. 2019 Aug 15;20(1):374. doi: 10.1186/s12891-019-2745-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PaRIS-IOR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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