Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT00839020
Status:
TERMINATED
Last Update Posted:
2016-07-26
First Post:
2009-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Number of patients willing to participate in the study too low', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2009-02-06', 'studyFirstSubmitQcDate': '2009-02-06', 'lastUpdatePostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity using the Visual Analogue Scale (VAS) regarding concomitant pain medication intake.', 'timeFrame': 'daily measurements for 20 postoperative days'}], 'secondaryOutcomes': [{'measure': 'Range of Motion (ROM)', 'timeFrame': 'daily measurements during hospital stay'}, {'measure': 'Knee Society Score (KSS)', 'timeFrame': 'preop, postop'}, {'measure': 'Oxford Knee Score (OKS)', 'timeFrame': 'preop, postop'}, {'measure': 'WOMAC-Score', 'timeFrame': 'preop, postop'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Surgical Procedures, Minimally Invasive', 'Range of Motion', 'Articular Arthroplasty, Replacement, Knee'], 'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Post-traumatic Arthritis']}, 'descriptionModule': {'briefSummary': '50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as concomitant pain medication are monitored during the first 20 postoperative days and will be compared for the two groups. Various scores are surveyed.', 'detailedDescription': 'Accuracy of implant positioning and reconstruction of the mechanical leg axis are major requirements for achieving good long-term results in total knee arthroplasty (TKA). A minimally invasive approach might compromise the accuracy due to lacking intraoperative oversight. The purpose of this study is to compare a minimally invasive TKA approach that was performed under control of a navigation system with a standard navigated approach, with respect to patient pain and range of motion.\n\nAll patients receive a Columbus knee prosthesis and in both groups an OrthoPilot navigation system is used to control the alignment. Pain intensity using the Visual Analogue Scale (VAS) and concomitant pain medication intake are documented daily during the first 20 days after operation. As long as the patient is hospitalized the Range of Motion will also be documented daily. Knee society score, oxford score, as well as the WOMAC score are monitored pre- and postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for elective TKA\n* agreement to participate in this study\n\nExclusion Criteria:\n\n* Body Mass Index (BMI)\\>40kg/m²\n* varus or valgus deformity \\>20°\n* Range of Motion (ROM) \\<75° flexion/extension\n* concomitant diseases like: rheumatoid arthritis osteoporosis intake of cortisone diabetes former operations on the concerned knee\n* infections in the operated joint during the follow-up period\n* Thromboses during the follow-up period'}, 'identificationModule': {'nctId': 'NCT00839020', 'briefTitle': 'Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Comparison of a Minimally Invasive and a Conventional Approach in Computer Assisted Total Knee Arthroplasty.', 'orgStudyIdInfo': {'id': 'MIOS-TKR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Navigated total knee arthroplasty with a minimally invasive approach', 'interventionNames': ['Procedure: Navigated TKA with a minimally invasive approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Navigated total knee arthroplasty with a conventional approach', 'interventionNames': ['Procedure: Navigated TKA with a conventional approach']}], 'interventions': [{'name': 'Navigated TKA with a minimally invasive approach', 'type': 'PROCEDURE', 'otherNames': ['Navigated MIS TKA'], 'description': 'Navigated total knee arthroplasty with a minimally invasive approach', 'armGroupLabels': ['1']}, {'name': 'Navigated TKA with a conventional approach', 'type': 'PROCEDURE', 'otherNames': ['Navigated TKA with conventional approach'], 'description': 'A navigated total knee arthroplasty is performed using the Orthopilot navigation system. A conventional approach is performed', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'Frank Lampe, MD', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Frank Lampe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schön Kliniken Klinikum Eilbek'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}