Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT03790267
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2018-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-29', 'size': 299259, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-28T17:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2018-12-28', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcomes: total score of the joint-specific functional scales.', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Functional outcomes: total score of the joint-specific functional scales.', 'timeFrame': '6 months after surgery', 'description': '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).'}, {'measure': 'Functional outcomes: total score of the joint-specific functional scales.', 'timeFrame': '12 months after surgery', 'description': '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).'}, {'measure': 'Euro-Quality-5-Dimensions questionnaire scores.', 'timeFrame': 'Baseline', 'description': "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)."}, {'measure': 'Euro-Quality-5-Dimensions questionnaire scores.', 'timeFrame': '6 months after surgery', 'description': "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)."}, {'measure': 'Euro-Quality-5-Dimensions questionnaire scores.', 'timeFrame': '12 months after surgery', 'description': "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)."}, {'measure': 'Visual analogue scale (EQ-VAS) scores', 'timeFrame': 'Baseline', 'description': '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".'}, {'measure': 'Visual analogue scale (EQ-VAS) scores', 'timeFrame': '6 months after surgery', 'description': '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".'}, {'measure': 'Visual analogue scale (EQ-VAS) scores', 'timeFrame': '12 months after surgery', 'description': '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".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Hip', 'Arthroplasty, Replacement, Knee', 'Arthroplasty, Replacement, Shoulder']}, 'referencesModule': {'references': [{'pmid': '36085337', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31416443', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nPaRIS-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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of consecutive patients undergoing hip, knee and shoulder arthroplasty. Patients will be enrolled at 6 operative units of the IOR (Orthopedic and Traumatological I Clinic, Orthopedic and Traumatological Clinic II, Orthopedic and Traumatologic Clinic III, Reconstructive Orthopedic Surgery - Innovative Techniques / Revision surgery of hip prosthesis and new implant development, Surgery of the Shoulder and Elbow, Orthopedics-Traumatology and Prosthetic Surgery and of hip and knee replanting). For patients accessing through the "hospitalization-before-surgery" pathway, the enrollment will take place in the specific ambulatory in the month preceding the intervention. The remaining patients will be enrolled directly at the operative Units involved.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females aged 18-95 years\n2. Be on the list for an elective primary arthroplasty of hip, knee or shoulder\n3. Availability to sign the informed consent\n\nExclusion Criteria:\n\n1. Severe cognitive impairment\n2. To be listed for arthroplasty for musculoskeletal cancer\n3. Not eligible for the surgical intervention'}, 'identificationModule': {'nctId': 'NCT03790267', 'acronym': 'PaRIS-IOR', 'briefTitle': 'Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Functional Outcomes and Quality of Life Reported by Adult Patients Undergoing Elective Hip, Knee and Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'PaRIS-IOR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hip arthroplasty', 'interventionNames': ['Other: Questionnaire administration']}, {'label': 'Knee arthroplasty', 'interventionNames': ['Other: Questionnaire administration']}, {'label': 'Shoulder arthroplasty', 'interventionNames': ['Other: Questionnaire administration']}], 'interventions': [{'name': 'Questionnaire administration', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Hip arthroplasty', 'Knee arthroplasty', 'Shoulder arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bologna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Orthopaedics', 'investigatorFullName': 'Stefano Zaffagnini', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}