Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT00889304
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Position HTO Multicenter NIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient health status improvement assessed by IKDC 2000 subjective knee score', 'timeFrame': '1 year after HTO'}], 'secondaryOutcomes': [{'measure': 'Improvement of further scores: Tegner Activity Score, Lysholm-Gillquist Score, Cincinnati-Sportsmedicine and Orthopaedic Center-Score, IKDC 2000 objective knee score, Hospital for Special Surgery Score (HSS)', 'timeFrame': '1 year after HTO'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HTO, high tibial osteotomy, open wedge, medial arthritis'], 'conditions': ['Medial Monocompartmental Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion: Varus deformity between 0 - 20°, Isolated medial arthrosis ≥ level 2 (K\\&L) OR a congenital deformity OR chondromalacia ≥ level 2 (ICRS), Lateral cartilaginous tissue damage ≤ level 1(K\\&L), Intact lateral meniscus, Age ≥ 18 years, Range of Motion at least 0° - 0° - 130°, Patella/ sliding plane without signifikant signs of arthrosis, Stable joint OR possibility of intraoperative balancing of the tendon tension;\n\nExclusion: Clinically relevant disorders of bone metabolism, Aktive infection, Adipositas (BMI ≥ 35), Rheumatoid arthritis, Osteomyelitis in the tibia, No availibility for follow-up examinations'}, 'identificationModule': {'nctId': 'NCT00889304', 'acronym': 'Position HTO', 'briefTitle': 'Position HTO Multicenter NIS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Study on Quality of Life in Patients With Unicompartmental Arthrosis After High Tibial Osteotomy With the Position HTO(R) System', 'orgStudyIdInfo': {'id': 'AAG-O-H-0702'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'HTO cohort', 'interventionNames': ['Device: Position HTO system']}], 'interventions': [{'name': 'Position HTO system', 'type': 'DEVICE', 'description': 'open wedge high tibial osteotomy', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83043', 'city': 'Bad Aibling', 'country': 'Germany', 'facility': 'Orthopädie Harthausen', 'geoPoint': {'lat': 47.8638, 'lon': 12.01055}}, {'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Caritas-Krankenhaus Bad Mergentheim', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '72108', 'city': 'Rottenburg', 'country': 'Germany', 'facility': 'Winghofer Medicum', 'geoPoint': {'lat': 48.47629, 'lon': 8.93528}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'BGU Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Jürgen Fritz, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Winghofer Medicum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Viktor Breul', 'oldOrganization': 'Aesculap AG'}}}}