Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT01192334
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2010-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-22', 'studyFirstSubmitDate': '2010-08-30', 'studyFirstSubmitQcDate': '2010-08-31', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'single limb standing balance', 'timeFrame': 'from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks', 'description': 'migration distance of center of pressure while single limb standing was recorded through balance performance monitoring'}, {'measure': 'single limb standing balance', 'timeFrame': 'from the surgery until the time in which patient shows the same pain score as the pre-operation pain score up to the post-operative 4 weeks, average time of this measurement is post-operative 2 weeks', 'description': 'migration distance of center of pressure while single limb standing was recorded through balance performance monitoring'}, {'measure': 'single limb standing balance', 'timeFrame': 'post-operative 6 months', 'description': 'migration distance of center of pressure while single limb standing was recorded through balance performance monitoring'}, {'measure': 'single limb standing balance', 'timeFrame': 'post-operative 12 months', 'description': 'migration distance of center of pressure while single limb standing was recorded through balance performance monitoring'}], 'secondaryOutcomes': [{'measure': 'balance index', 'timeFrame': 'from issuing admision paper before the surgery up to 4 weeks, average time of this measurement is 2 weeks', 'description': 'balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine'}, {'measure': 'balance index', 'timeFrame': 'post-operative 6 months', 'description': 'balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine'}, {'measure': 'balance index', 'timeFrame': 'post-operative 12 months', 'description': 'balance index, calculated ratio from the deviated distance and time from the neutral point, was collected by using the Biodex machine'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['knee osteoarthritis arthroplasty postural balance'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'It was well known that total knee arthroplasty could improve the previously impaired proprioception in degenerative osteoarthritis. Most current researches have been focused on the change of the proprioception. However, the evaluation of the proprioception is based on the surrogated end.\n\nDouble or single limb standing balance is considered functional scale. It is very important view for the prevention of slipping down injury in evidence-based approaches for knee osteoarthritis.\n\nUnfortunately, few study have been performed for figuring proprioceptive change after surgery out.\n\nConsidering the similarity between the proprioception and the standing balance and reported positive result in proprioception after total knee arthroplasty, the investigators supposed that total knee arthroplasty might give an influence on the recovery of single limb standing balance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients to be scheduled to take a elective unilateral total knee arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medial compartment degenerative knee osteoarthritis showing the varus deformity\n\nExclusion Criteria:\n\n* History of surgery on the lower extremity except for arthroscopy or menisectomy\n* Hip arthritis or, hip or back pain disturbing the standing\n* History of participation in sport rehabilitation program within less than 6 months\n* Presence of neurological or musculoskeletal disease disturbing the standing\n* Patient to reject the participation'}, 'identificationModule': {'nctId': 'NCT01192334', 'briefTitle': 'Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Ulsan University Hospital'}, 'officialTitle': 'Observational Study for Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis', 'orgStudyIdInfo': {'id': 'chhwang1'}}, 'contactsLocationsModule': {'locations': [{'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Chang Ho Hwang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ulsan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Chang Ho Hwang', 'investigatorAffiliation': 'Ulsan University Hospital'}}}}