Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-02-19 @ 11:35 AM
Study NCT ID:
NCT05404568
Status:
UNKNOWN
Last Update Posted:
2022-06-03
First Post:
2022-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Hierarchical Rehabilitation After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-31', 'studyFirstSubmitDate': '2022-05-31', 'studyFirstSubmitQcDate': '2022-05-31', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction of patients of total knee arthroplasty', 'timeFrame': '12 months after Total Knee Arthroplasty', 'description': 'Satisfaction of patients（1-10 scoring）'}, {'measure': 'HSS-KS score', 'timeFrame': '12 months after Total Knee Arthroplasty', 'description': 'Hospital For Special Surgery Knee Score'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale of patients', 'timeFrame': '3 weeks，3 and 12 months after Total Knee Arthroplasty', 'description': 'Visual analog scale of patients'}, {'measure': 'Range of motion', 'timeFrame': '3 weeks，3 and 12 months after Total Knee Arthroplasty', 'description': 'Range of motion of undergoing surgery'}, {'measure': '10mWT', 'timeFrame': '3 weeks，3 and 12 months after Total Knee Arthroplasty', 'description': '10 meters working test'}, {'measure': 'WOMAC', 'timeFrame': '3 weeks，3 and 12 months after Total Knee Arthroplasty', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index'}, {'measure': 'SF-36', 'timeFrame': '3 weeks，3 and 12 months after Total Knee Arthroplasty', 'description': '36-Item Short Form Survey'}, {'measure': 'Satisfaction of patients of total knee arthroplasty', 'timeFrame': '3 weeks，3 months after Total Knee Arthroplasty', 'description': 'Satisfaction of patients（1-10 scoring）'}, {'measure': 'HSS-KS score', 'timeFrame': '3 weeks，3 months after Total Knee Arthroplasty', 'description': 'Hospital For Special Surgery Knee Score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rehabilitation；Arthroplasty, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis (KOA) is one of the diseases that seriously affect the quality of human life, resulting in a significant disease burden. Total knee arthroplasty (TKA) is one of the ultimate treatments for knee osteoarthritis. Functional recovery after total knee arthroplasty depends on rehabilitation. With the incidence rate of knee osteoarthritis increasing, the amount of knee replacement surgery is increasing rapidly, the demand for medical resources and medical expenditure has increased.\n\nAt present, there are many rehabilitation pathways after total knee arthroplasty, but there is no unified evidence-based medicine guide to guide postoperative rehabilitation. The current early rehabilitation pathways after total knee arthroplasty in China can be generally divided into three categories: inpatient rehabilitation, outpatient rehabilitation and home-based self-rehabilitation. The intensity and expenditure of rehabilitation treatment decrease in turn.\n\nIndividual differences among patients lead to different rehabilitation treatment needs for functional recovery. How to predict the rehabilitation needs of patients after total knee arthroplasty and choose an appropriate rehabilitation pathway based on themselves need to be solved.\n\nWe expected to establish a prediction model that we will be able to inform patients with knee osteoarthritis who just taken total knee arthroplasty and want to choose a pathway to rehabilitation by using the baseline status, that will help them to choose their best pathway to rehabilitation -- provide rehabilitation according to needs, save costs and improve the quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with knee osteoarthritis who will take total knee arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ① Knee osteoarthritis was diagnosed and total knee arthroplasty was planned;\n* ② Good cognitive function, can cooperate and understand the contents of this test, and is willing to cooperate with rehabilitation evaluation and postoperative follow-up during perioperative period;\n* ③ Aged 18 and above, voluntarily participated in the study and signed informed consent.\n\nExclusion Criteria:\n\n* ① Accompanied by other local or systemic diseases that seriously affect the function of lower limbs, such as severe lumbar spinal stenosis, severe rheumatoid arthritis, etc;\n* ② Patients have consciousness disorders, cognitive disorders, serious mental disorders and other diseases that affect limb function and cognition.'}, 'identificationModule': {'nctId': 'NCT05404568', 'briefTitle': 'The Hierarchical Rehabilitation After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'The Hierarchical Rehabilitation After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'M2022120'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'We included patients with knee osteoarthritis who planned to take total knee arthroplasty'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100089', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Boyang Yu, M.D.', 'role': 'CONTACT', 'email': 'accept@pku.edu.cn', 'phone': '+8601082266771'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}