Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01450904
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2011-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2011-10-10', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The recovery time of Quadriceps strength', 'timeFrame': 'Upto 6 months', 'description': 'Quadriceps strength was tested every month postoperatively, Recovery time was the amount of months which the Quadriceps strength returned to preoperative level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of Knee']}, 'descriptionModule': {'briefSummary': 'Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the less postoperative pain and shorter recovery time compared to the conventional technique. With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more quadriceps strength and improve functional performance after TKA. However, there was no previous studies about the effect of quadriceps incision length in the recovery time of the quadriceps strength. The investigators hypothesized that longer quadriceps incision affected the longer recovery time of quadriceps strength in MIS-TKA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients who diagnosed primary osteoarthritis of knee with\n\n 1. varus or valgus deformity \\< 20 degrees\n 2. preoperative range of motion \\> 90 degrees\n 3. extension lag \\< 10 degrees\n 4. Flexion contracture \\< 30 degrees\n\nExclusion Criteria:\n\n* Bilateral simultaneous total knee arthroplasty\n* Previous knee surgery\n* Inadequate exposure during the surgery'}, 'identificationModule': {'nctId': 'NCT01450904', 'briefTitle': 'The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty: The Effect of Quadriceps Incision Length', 'orgStudyIdInfo': {'id': 'Si051/2554(EC2)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'The length of Quadriceps incision was less than 2 cm.', 'interventionNames': ['Procedure: Quadriceps incision < 2 cm']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'The length of Quadriceps incision was 2 to 4 cm.', 'interventionNames': ['Procedure: Quadriceps incision 2-4 cm']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'The length of Quadriceps incision was more than 4 cm.', 'interventionNames': ['Procedure: Quadriceps incision > 4 cm']}], 'interventions': [{'name': 'Quadriceps incision < 2 cm', 'type': 'PROCEDURE', 'description': 'MIS-TKA was performed with less than 2 cm Quadriceps incision length', 'armGroupLabels': ['Group A']}, {'name': 'Quadriceps incision 2-4 cm', 'type': 'PROCEDURE', 'description': 'MIS-TKA was performed with 2 to 4 cm Quadriceps incision length', 'armGroupLabels': ['Group B']}, {'name': 'Quadriceps incision > 4 cm', 'type': 'PROCEDURE', 'description': 'MIS-TKA was performed with more than 4 cm Quadriceps incision length', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Keerati Charoencholvanich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}