Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 8:37 PM
Study NCT ID:
NCT04524312
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2020-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Congruence Total Knee Replacement vs Posterior-stabilized
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}, {'id': 'D001696', 'term': 'Biomechanical Phenomena'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D055592', 'term': 'Biophysical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant will not be informed which type of prosthesis was used in their particular case.\n\nOutcomes Assessor will not be informed which type of prosthesis was used in particular patient.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-26', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-19', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of swing phase', 'timeFrame': 'Time Frame: 1-3 years after surgery', 'description': 'Change from baseline part of swing phase time during gait, measured in percentage\n\nChange from baseline part of swing phase time during gait, measured in percentage'}, {'measure': 'Time of stance phase', 'timeFrame': 'Time Frame: 1-3 years after surgery', 'description': 'Change from baseline part of stance phase time during gait, measured in percentage'}, {'measure': 'Time of double-stance phase', 'timeFrame': 'Time Frame: 1-3 years after surgery', 'description': 'Change from baseline part of double-stance phase time during gait, measured in percentage'}, {'measure': 'Stride length', 'timeFrame': 'Time Frame: 1-3 years after surgery', 'description': 'Change from baseline length of stride during gait, measured in meters'}, {'measure': 'Cadence', 'timeFrame': 'Time Frame: 1-3 years after surgery', 'description': 'Change from baseline number of strides per minute of walking'}, {'measure': 'Mean gait velocity', 'timeFrame': 'Time Frame: 1-3 years after surgery', 'description': 'Change from baseline mean values of gait speed, measured in meters per second'}, {'measure': 'Range of maximal hip extension for both limbs during ending part of mid-stance phase', 'timeFrame': 'Time Frame: 1-3 years after surgery', 'description': 'Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees'}, {'measure': 'Range of pelvic drop in frontal plane on the opposite site of the bearing limb', 'timeFrame': 'Time Frame: 1-3 years after surgery', 'description': 'Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'congruence', 'posterior-stabilized', 'cruciate-retaining'], 'conditions': ['Osteo Arthritis Knee', 'Surgery', 'Joint Diseases']}, 'descriptionModule': {'briefSummary': 'This study compares and evaluates differences in movement analysis, patient-reported outcome between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen with posterior stabilization and Bioimplanti K-Mod cruciate-retaining with dynamic congruence', 'detailedDescription': "The aim of this study is to assess and compare kinematic and time-space gait parameters in patients after total knee arthroplasty, who will undergo the surgery with the use of either posterior-stabilized (PS) or dynamic congruence (DC) implants.\n\nMaterials and methods To this study 56 consecutive patients undergoing total knee arthroplasty will be recruited. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization \\[1:1\\]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.\n\nBefore the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity and VAS (Visual Analogue Scale).\n\nAfter the surgery 1 to 3 years postoperatively three-dimensional gait analysis will performed with use of BTS SMART device. This device uses passive markers technology and registers the movement by six cameras. To perform full gait analysis several data concerning patients anthropometry will be collected (lower limb length, knee and ankle joint width, width and depth of the pelvis). Whole gait analysis will be performed by experienced single clinical biomechanist accordingly to the Davis protocol. Markers will be installed on the patients' limbs on the following points: base of sacral bone, greater trochanter of the femur, lateral femoral condyle, head of the fibula, lateral malleoli, head of the V metatarsal bone).\n\nParticipants will walk barefoot for 10 meters quadruple times. Following time-space and kinematic parameters will be assessed:\n\nTime-space parameters Single stance time (T1) \\[%\\] Swing time (T2) \\[%\\] Double-stance time (T3) \\[%\\] Step length (SL) \\[m\\] Mean gait velocity (Vm) \\[m/s\\] Cadence (C) \\[number of steps/min\\]\n\nKinematic parameters:\n\nOperated knee range of flexion during swing phase \\[°\\]"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* agreement to participate in the study\n* BMI (kg/m2) less than 40\n* ability to walk for 10 meters\n* knee flexion more or equal of 90 degrees\n\nExclusion Criteria:\n\n* unwillingness to participate in the study\n* osteoarthritis due to the rheumatological disease\n* disorders associated with nerve-muscle signal transmission\n* neurological disorders associated with dizziness, nystagmus or other conditions that might influence balance during activity'}, 'identificationModule': {'nctId': 'NCT04524312', 'acronym': 'K-Mod', 'briefTitle': 'Dynamic Congruence Total Knee Replacement vs Posterior-stabilized', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Does Dynamic Congruence Design Improve Gait After Total Knee Replacement in Comparison to Posterior-stabilized One? - Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'WarsawMU/kmod'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NexGen', 'description': 'Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis', 'interventionNames': ['Procedure: Total knee replacement', 'Diagnostic Test: Biomechanics', 'Device: NexGen Ps or Bioimplanti K-MOD implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'K-Mod', 'description': 'Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Bioimplanti K-MOD prosthesis', 'interventionNames': ['Procedure: Total knee replacement', 'Diagnostic Test: Biomechanics', 'Device: NexGen Ps or Bioimplanti K-MOD implant']}], 'interventions': [{'name': 'Total knee replacement', 'type': 'PROCEDURE', 'description': 'Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior-stabilized or retaining cruciate-retaining with dynamic congruence implant', 'armGroupLabels': ['K-Mod', 'NexGen']}, {'name': 'Biomechanics', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively', 'armGroupLabels': ['K-Mod', 'NexGen']}, {'name': 'NexGen Ps or Bioimplanti K-MOD implant', 'type': 'DEVICE', 'description': 'Participant are randomly allocated to receive one of the NexGen PS or Biomplanti K-MOD total knee implant for treatment of end-stage knee osteoarthritis.', 'armGroupLabels': ['K-Mod', 'NexGen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03-984', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Department of Othopedics and Rehabilitation, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Bartosz M. Maciąg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Artur Stolarczyk', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}