Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 11:50 PM
Study NCT ID:
NCT01160835
Status:
COMPLETED
Last Update Posted:
2010-07-12
First Post:
2010-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-09', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the clinic and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach', 'timeFrame': '2 years', 'description': 'Perioperative parameters: operative time, blood loss, Doses of narcotics for pain control, peri-operative complications Postoperative parameters: VAS, range of motion, knee functional score, isokinetic studies, radiographic alignment, complications'}], 'secondaryOutcomes': [{'measure': 'To compare the survival and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach at 2-year follow-up.', 'timeFrame': '5 and 10 years', 'description': 'Postoperative parameters: VAS, range of motion, knee functional score, isokinetic studies, radiographic alignment and failure rate of knee prothesis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'minimally invasive', 'quadriceps-sparing', 'Quadriceps-sparing total knee arthroplasty'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Quadriceps-sparing minimally invasive total knee arthroplasty (TKA) with side-cutting instruments has been proposed to limit surgical dissection without compromising the surgical outcome. We conducted a prospective, randomized study to compare the outcomes of quadriceps-sparing TKA with conventional medial parapatellar TKA, with two-year follow-up.\n\nWe hypothesize that the quadriceps-sparing arthrotomy would not outperform the conventional medial parapatellar arthrotomy in TKA, in terms of postoperative recovery of quadriceps muscle strength, alignment of the prosthetic knee, and clinical outcome.', 'detailedDescription': 'Eighty primary TKAs in sixty patients of osteoarthritis constituted this study. Patients were randomly assigned to either quadriceps-sparing (QS, 40 knees) or medial parapatellar (MP, 40 knees) group. All surgeries were designed to set the prosthesis with thefemoral component alignment of 7º valgus and the tibial component alignment perpendicular to tibial shaft. Outcome variables included knee function defined by Hospital for Special Surgery knee score, quadriceps muscle strength measured by isokinetic dynamometer, pain indicated on visual analogue scale, range of motion, and post-operative alignment measured on plain radiograph.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* advanced osteoarthritis with radiograph-evident narrowing of joint gap,\n* with persistent symptoms after conservative treatment for at least 6 months, and\n* patients' intention to receive the prosthetic TKA.\n\nExclusion Criteria:\n\n* the knees with excessive deformity of femorotibial angle exceeding 15° varus or 10° valgus,\n* flexion contracture exceeding 15°,\n* active infection involving the knees, or\n* knees received previous surgery."}, 'identificationModule': {'nctId': 'NCT01160835', 'briefTitle': 'Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '9561705022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadriceps-sparing total knee arthroplasty', 'description': 'Quadriceps-sparing arthrotomy with side-cutting instruments', 'interventionNames': ['Procedure: total knee arthroplastyinstruments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medial parapatellar total knee arthroplasty', 'description': 'Medial parapatellar arthrotomy with front-cutting instruments', 'interventionNames': ['Procedure: total knee arthroplastyinstruments']}], 'interventions': [{'name': 'total knee arthroplastyinstruments', 'type': 'PROCEDURE', 'description': 'Quadriceps-sparing arthrotomy with side-cutting instruments', 'armGroupLabels': ['Medial parapatellar total knee arthroplasty', 'Quadriceps-sparing total knee arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Orthopedic Surgery, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hongsen Chiang, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of orthopedic surgery of National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ching-Chuan Jiang, Professor', 'oldOrganization': 'Department of Orthopaedic Surgery of National Taiwan University Hospital'}}}}