Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-31 @ 4:43 PM
Study NCT ID:
NCT04968600
Status:
UNKNOWN
Last Update Posted:
2021-07-20
First Post:
2021-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Arthroplasties
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double (Participant, Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-08', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'smart-phone based gait analysis', 'timeFrame': 'Change from preoperative gait analysis at 3rd month gait analysis', 'description': 'Gait analysis is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application'}, {'measure': 'smart-phone based gait analysis', 'timeFrame': 'Change from 3rd month gait analysis at 6th month gait analysis', 'description': 'Gait analysis is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application'}, {'measure': 'smart-phone based gait analysis', 'timeFrame': 'Change from 6th month gait analysis at 12th month gait analysis', 'description': 'Gait analysis is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application'}], 'secondaryOutcomes': [{'measure': 'Knee functional scores', 'timeFrame': 'Change from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)', 'description': 'Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )'}, {'measure': 'Knee functional scores', 'timeFrame': 'Change from 3rd month Knee Society Scores (KSS) at 6th month Knee Society Score (KSS)', 'description': 'Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )'}, {'measure': 'Knee functional scores', 'timeFrame': 'Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)', 'description': 'Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee arthroplasty', 'gait analysis', 'smart-phone'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'In total knee arthroplasty (TKA), the posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) techniques are widely used depending on the individual preference of the surgeon. Comparative analysis of these two techniques is a major topic of investigation in arthroplasty research. The hypothesis of the present study is that compared with the CR technique, the PS technique is associated with a worse gait pattern. Smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing total knee arthroplasty with a CR and a PS technique, at 3, 6, and 12 months postoperatively.', 'detailedDescription': "Patients undergoing total knee arthroplasty are randomized to posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) groups by generating random numbers with Microsoft Excel. The patients are/will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (KSS and KOOS), life quality (SF-12), and smart-phone based gait analysis. All data will be calculated as mean and standard deviation values. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of unilateral primary knee osteoarthritis\n* Age 55 to 85 years\n* Must be able to walk without support\n\nExclusion Criteria:\n\n* Rheumatological joint diseases\n* Previous knee surgery\n* Neuromuscular diseases\n* Bilateral knee osteoarthritis\n* Insufficiency of knee collateral ligaments.'}, 'identificationModule': {'nctId': 'NCT04968600', 'briefTitle': 'Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Arthroplasties', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gulhane Training and Research Hospital'}, 'officialTitle': 'Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Total Knee Arthroplasties: Gait Analysis With a Smartphone Application', 'orgStudyIdInfo': {'id': '2021/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Posterior-cruciate-ligament-retaining (CR)', 'description': 'Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty', 'interventionNames': ['Procedure: total knee arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'posterior-cruciate-ligament-stabilized (PS)', 'description': 'Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty', 'interventionNames': ['Procedure: total knee arthroplasty']}], 'interventions': [{'name': 'total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty', 'armGroupLabels': ['Posterior-cruciate-ligament-retaining (CR)', 'posterior-cruciate-ligament-stabilized (PS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Deniz CANKAYA, Assoc.Prof.', 'role': 'CONTACT', 'email': 'cankayadeniz78@gmail.com', 'phone': '+905426688056'}, {'name': 'Denizhan SIVRI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gulhane Teaching and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Deniz CANKAYA, Assoc.Prof.', 'role': 'CONTACT', 'email': 'cankayadeniz78@gmail.com', 'phone': '+90 542 6688056'}], 'overallOfficials': [{'name': 'Deniz CANKAYA, Assoc.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Gulhane Teaching and Research Hospital'}, {'name': 'Denizhan SIVRI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gulhane Teaching and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Deniz CANKAYA', 'investigatorAffiliation': 'Gulhane Training and Research Hospital'}}}}