Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 8:42 AM
Study NCT ID:
NCT01797003
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2013-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2013-02-20', 'studyFirstSubmitQcDate': '2013-02-20', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oxford knee score', 'timeFrame': '2 years', 'description': 'The change in Oxford score are followed at several time points the first 2 years. Patients will be evaluated with Oxford knee score, 3 months, 6 months, 1 year and 2 years postoperatively.'}, {'measure': 'Lysholm score', 'timeFrame': '2 years postoperatively', 'description': 'The change in Lysholm score are followed at several time points the first 2 years. Patients will be evaluated with Lysholm, 3 months, 6 months, 1 year and 2 years postoperatively.'}, {'measure': 'UCLA activity scale', 'timeFrame': '2 years postoperatively', 'description': 'The change in UCLA scale are followed at several time points the first 2 years. Patients will be evaluated with UCLA activity scale, 3 months, 6 months, 1 year and 2 years postoperatively.'}, {'measure': 'Tegner Activity Score', 'timeFrame': '2 years postoperatively', 'description': 'The change in Tegner score are followed at several time points the first 2 years. Patients will be evaluated with Tegner score, 3 months, 6 months, 1 year and 2 years postoperatively.'}], 'primaryOutcomes': [{'measure': 'Kne injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '2 years postoperataively', 'description': 'The change in KOOS score are followed at several time points the first 2 years. Patients will be evaluated with KOOS, 3 months, 6 months, 1 year and 2 years postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Range of motion (ROM)', 'timeFrame': '2 years postoperatively', 'description': 'The change in ROM are followed at several time points the first 2 years. ROM will be measured 3 months, 6 months, 1 year and 2 years postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'osteotomy', 'closing', 'opening', 'wedge', 'kne', 'tibia'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis.\n\nOpening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.', 'detailedDescription': 'Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods.\n\nTime-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.\n\nIn a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medial osteoarthritis in the knee (x-ray and arthroscopy)\n* Pain in medial compartment of the knee\n* Correction angle of 5 degrees or more\n\nExclusion Criteria:\n\n* Former or active infection in the knee\n* Rheumatoid arthritis or other similar disease\n* Cancer\n* Neurological disease\n* Kidney disease or metabolic disease'}, 'identificationModule': {'nctId': 'NCT01797003', 'briefTitle': 'Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.', 'organization': {'class': 'OTHER', 'fullName': 'Vestre Viken Hospital Trust'}, 'officialTitle': 'Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.', 'orgStudyIdInfo': {'id': 'TKN-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Opening wedge HTO', 'description': 'Opening wedge high tibial osteotomy using Puddu plate', 'interventionNames': ['Other: High tibial osteotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Closing wedge HTO', 'description': 'Closing wedge high tibial osteotomy using cramp fixation', 'interventionNames': ['Other: High tibial osteotomy']}], 'interventions': [{'name': 'High tibial osteotomy', 'type': 'OTHER', 'armGroupLabels': ['Closing wedge HTO', 'Opening wedge HTO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0756', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Martina Hansens Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Tor Kjetil Nerhus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant orthopaedic surgeon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'South-Eastern Norway Regional Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Orthopaedic surgeon', 'investigatorFullName': 'Tor Kjetil Nerhus', 'investigatorAffiliation': 'Vestre Viken Hospital Trust'}}}}