Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-30 @ 12:56 PM
Study NCT ID:
NCT06249958
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transforming Rehabilitation: Personalised Care for a Better Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Barthel Index Total score', 'timeFrame': 'through study completion, within four years', 'description': '0-100, the higher, the better'}, {'measure': 'Functional autonomy measure (total score)', 'timeFrame': 'through study completion, within four years', 'description': '0-126, the higher, the better'}, {'measure': 'Standard hospital evaluation of patient gait', 'timeFrame': 'through study completion, within four years', 'description': 'Autonomous, autonomous maximum 50 metres, or non autonomous.'}, {'measure': 'Standard hospital evaluation of walking aids needed by the patient', 'timeFrame': 'through study completion, within four years', 'description': 'Crutches, stick, walker.'}, {'measure': 'Standard hospital evaluation of place of discharge', 'timeFrame': 'through study completion, within four years', 'description': 'Home with relatives, home alone, residential care facility.'}, {'measure': 'Standard hospital evaluation of care burden at discharge', 'timeFrame': 'through study completion, within four years', 'description': 'Less than 6 hours a day; less than 3 hours a day; no burden.'}, {'measure': 'Patient-reported outcomes', 'timeFrame': 'through study completion, within four years', 'description': 'Visual Analog Scale (VAS), 0-10, the higher, the better; Short-Form 12, Physical and Mental Scores, 0-100, the higher, the better; Euro QOL - 5 Dimension (EQ-5D), 0-100, the higher, the better; Hip Disability and Osteoarthritis Outcome Score (HOOS), 0-100, the higher, the better; Knee Injury and Osteoarthritis Outcome Score (KOOS), 0-100, the higher, the better.'}, {'measure': 'Functional autonomy measure subdomains', 'timeFrame': 'through study completion, within four years', 'description': 'Mobility, 3-21, the higher, the better; Cognition, 3-21, the higher, the better.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis Secondary', 'Osteoarthritis Primary', 'Osteoarthritis, Knee', 'Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'General aim of the project: building and validating an Artificial Intelligence (AI)-based prediction model on rehabilitation outcomes (total joint replacement - TJR - of the hip and knee for primary and secondary osteoarthritis)\n\nPurpose of this specific approval request: identifying data from patients admitted for total joint replacement surgery (hip and knee) at Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Galeazzi (IOG) in 2019 and subsequently discharged to inpatient rehabilitation in the same institution.', 'detailedDescription': 'The aim is to collect data from patients undergoing elective TJR (baseline, intervention, outcomes) in order to generate and train an AI algorithm.\n\nPatient characteristics (diagnosis, sex, age, American Society of Anesthesiologists (ASA) score, profession, haemoglobin levels, pain, functional autonomy, care giver presence at home), intervention characteristics (surgical procedure, day of surgery, duration of surgery, infection occurrence, need of transfusion, length of hospital stay, verticalization day, rehabilitation program) and outcomes (Barthel Index, functional independence measures, care burden, Patient Reported Outcomes - PROs - when available ) are collected by the Principal Investigator in a dedicated Excel sheet.\n\nThe dataset includes information from the entire perioperative care:\n\n* Pre-surgery\n* Surgical procedure\n* Inpatient rehabilitation\n* Post discharge, if available, at 3,6,12,24,60 months.\n\nSuch new dataset will by employed to enable a software whose goal is to provide a predictive model for rehabilitation outcomes, which future application would be helping clinicians design evidence-based, personalized rehabilitation programs. The software will be developed by dedicated data science partners within the European Health and Digital Executive Agency (HADEA) research Project n. 101080288, PREPARE.\n\nThe study will include elective prosthetic surgery (TJR of the hip and knee) performed in 2019 (January-December) and the subsequent inpatient rehabilitation program.\n\nData collection will start after approval from the Ethical Committee (EC) and the new dataset must be available before spring 2024. However, retrieving further data may result necessary by general project needs which are currently not entirely foreseeable, therefore we ask authorization for the entire study duration of four years.\n\nInclusion criteria:\n\n* Patients admitted for inpatient surgery at IOG in 2019 (January-December) and subsequently discharged to inpatient rehabilitation in the same structure.\n* Ages ≥18 years\n* International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9CM) Diagnoses: 715.15, 16, 25, 26 (primary and secondary osteoarthritis of the hip and knee)\n* ICD-9CM Surgical procedures: 81.51, 81.54 (total joint replacement of the hip and knee).\n\nNo exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing a) hip or knee prostethic surgery after primary or secondary osteoarthritis at Galeazzi Orthopedic Hospital, year 2019; b) subsequent inpatient rehabilitation at the same facility.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted for inpatient surgery at IRCCS Galeazzi Orthopedic Institute in 2019 (January-December) and subsequently discharged to inpatient rehabilitation in the same structure.\n* Ages ≥18 years\n* International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9CM) Diagnoses: 715.15, 16, 25, 26 (primary and secondary osteoarthritis of the hip and knee)\n* ICD-9CM Surgical procedures: 81.51, 81.54 (total joint replacement of the hip and knee).\n\nExclusion Criteria: N/A'}, 'identificationModule': {'nctId': 'NCT06249958', 'acronym': 'PREPARE', 'briefTitle': 'Transforming Rehabilitation: Personalised Care for a Better Quality of Life', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, 1st Part)', 'orgStudyIdInfo': {'id': 'PREPARE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': 'Specific rehabilitation exercises'}, {'name': 'Verticalisation', 'type': 'OTHER', 'description': 'Day of patient verticalisation after surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20157', 'city': 'Milan', 'state': 'Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federico Pennestri, PhD', 'role': 'CONTACT', 'email': 'federico.pennestri@grupposandonato.it', 'phone': '0283502224'}], 'facility': "IRCCS Ospedale Galeazzi Sant'Ambrogio", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Federico Pennestri, PhD', 'role': 'CONTACT', 'email': 'federico.pennestri@grupposandonato.it', 'phone': '0283502224'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}