Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT00761956
Status:
COMPLETED
Last Update Posted:
2012-07-16
First Post:
2008-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Compare the NexGen CR and CR-Flex Knee Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kacy.arnold@zimmer.com', 'phone': '574-371-8336', 'title': 'Kacy Arnold, Associate Director, Clinical Affairs', 'organization': 'Zimmer, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CR Flex Fixed Bearing Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.', 'otherNumAtRisk': 87, 'otherNumAffected': 2, 'seriousNumAtRisk': 87, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'CR Standard Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR Knee.', 'otherNumAtRisk': 102, 'otherNumAffected': 6, 'seriousNumAtRisk': 102, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Other Knee Related Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Stiff Knee Resulting in Manipulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Death'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Wound Dehiscence'}, {'term': 'Articular Polyethylene Excessive Wear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Polyethylene Wear'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Range of Motion (ROM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CR Flex Fixed Bearing Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.'}, {'id': 'OG001', 'title': 'CR Standard Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR Knee.'}], 'classes': [{'categories': [{'measurements': [{'value': '119.1', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '120.7', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Months', 'description': "The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.", 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There was one case in the CR Standard Knee cohort where the Range of Motion was not complete. Therefore, the total number analyzed is 47 and not 48.'}, {'type': 'SECONDARY', 'title': 'Return to Function (RtF) Via Knee Scoiety Score (Modified)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CR Flex Fixed Bearing Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.'}, {'id': 'OG001', 'title': 'CR Standard Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR Knee.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.9', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '85.1', 'spread': '16.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Months', 'description': 'Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.\n\nGrading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There was one case in the CR Flex Fixed cohort and 3 in the CR Standard Knee cohort where the Return to Function was not complete. Therefore, the total number analyzed is 51 instead of 52 and 45 instead of 48 respectfully.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CR Flex Fixed Bearing Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.'}, {'id': 'FG001', 'title': 'CR Standard Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR Knee.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '34'}]}]}], 'recruitmentDetails': 'Patients were enrolled between 2004 and 2008 at a total of 15 sites throughout the USA'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CR Flex Fixed Bearing Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.'}, {'id': 'BG001', 'title': 'CR Standard Knee', 'description': 'Study arm will consist of patients that are treated with the NexGen CR Knee.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2012-04-02', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-12', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Range of Motion (ROM)', 'timeFrame': '24 Months', 'description': "The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded."}], 'secondaryOutcomes': [{'measure': 'Return to Function (RtF) Via Knee Scoiety Score (Modified)', 'timeFrame': '24 Months', 'description': 'Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.\n\nGrading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Osteoarthritis', 'Knee'], 'conditions': ['Total Knee Arthroplasty', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.', 'detailedDescription': 'This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age, 21-80 years\n* Sex, Male and Females will be included\n* BMI less than or equal to 39\n* Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history.\n* Patient is willing and able to cooperate in follow-up therapy.\n* Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.\n* Patient has stable and functional posterior cruciate and collateral ligaments.\n* Patient has potential to perform higher than average range of motion activities.\n* Operative side range of motion flexion greater than or equal to 120 degrees.\n* Severe knee pain and disability due to degenerative joint disease.\n* Patient or patient's legal representative has signed the Informed Consent form.\n\nExclusion Criteria:\n\n* Previous history of infection in the affected joint.\n* Previously failed knee endoprosthesis of any kind.\n* Charcot joint disease or other severe neurosensory deficits.\n* Previous patellectomy\n* Patient is skeletally immature.\n* Grossly insufficient femoral or tibial bone stock.\n* Patient is pregnant.\n* Varus or valgus deformity greater than 20 degrees.\n* Fixed flexion deformity greater than 15 degrees.\n* Previous high tibial osteotomy.\n* Previous femoral osteotomy.\n* Patient is a poor compliance risk, currently treated for ethanol or drug abuse, physical or mental handicap, etc.\n* Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance."}, 'identificationModule': {'nctId': 'NCT00761956', 'briefTitle': 'A Study to Compare the NexGen CR and CR-Flex Knee Implants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Prospective Randomized Multicenter Study of NexGen CR-Flex Knee', 'orgStudyIdInfo': {'id': '04-300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.', 'interventionNames': ['Device: NexGen CR-Flex Fixed Bearing Knee']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Study arm will consist of patients that are treated with the NexGen CR Knee.', 'interventionNames': ['Device: NexGen CR Knee']}], 'interventions': [{'name': 'NexGen CR-Flex Fixed Bearing Knee', 'type': 'DEVICE', 'otherNames': ['CR-Flex Knee'], 'description': 'NexGen CR-Flex Fixed Bearing femoral component', 'armGroupLabels': ['1']}, {'name': 'NexGen CR Knee', 'type': 'DEVICE', 'otherNames': ['CR Knee'], 'description': 'NexGen Complete Knee Solution Cruciate Retaining femoral component', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19963', 'city': 'Milford', 'state': 'Delaware', 'country': 'United States', 'facility': 'Dickinson Medical Group, LLC', 'geoPoint': {'lat': 38.91261, 'lon': -75.42797}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Orthopedic Associates', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '49525', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Orthopaedic Associates of Grand Rapids, PC', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pinehurst Surgical Center', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Slocum Orthopedics, PC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '15025', 'city': 'Clairton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Orthopedic Group', 'geoPoint': {'lat': 40.29229, 'lon': -79.88171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}