Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT00878358
Status:
COMPLETED
Last Update Posted:
2011-04-28
First Post:
2009-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-27', 'studyFirstSubmitDate': '2009-04-07', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed up and go test', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Oxford knee score', 'timeFrame': '6 weeks'}, {'measure': 'Visual analogue pain score', 'timeFrame': '6 weeks'}, {'measure': 'Range of knee motion', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Total knee replacement'], 'conditions': ['Osteoarthritis', 'Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nTo compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group.\n\nSecondary objectives:\n\nTo compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group based on measurements of timed up and go (TUG, as primary outcome), range of motion, pain and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidates for first total knee replacement surgery.\n\n * Age over 18.\n * Diagnosed with Osteoarthritis.\n * Consent to participate in the trial.\n\nExclusion Criteria:\n\n* \\- Rheumatic diseases.\n* Neurological diseases involving lower limbs.\n* Prior knee surgery in operated knee.\n* Secreting surgical wound.\n* Skin diseases.\n* Incontinence.\n* Incapable of signing informed consent.\n* Patients living outside Jerusalem'}, 'identificationModule': {'nctId': 'NCT00878358', 'briefTitle': 'Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR', 'orgStudyIdInfo': {'id': 'Hydrotherapy-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy', 'interventionNames': ['Other: Physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Hydrotherapy', 'interventionNames': ['Other: Hydrotherapy']}], 'interventions': [{'name': 'Hydrotherapy', 'type': 'OTHER', 'armGroupLabels': ['Hydrotherapy']}, {'name': 'Physiotherapy', 'type': 'OTHER', 'armGroupLabels': ['Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Leonid Kandel', 'oldOrganization': 'Hadassah Medical Center'}}}}