Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 8:41 AM
Study NCT ID:
NCT01473992
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mhighsmi@health.usf.edu', 'phone': '8139743806', 'title': 'M. Jason Highsmith', 'organization': 'University of South Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prosthetic Knee 1', 'description': "Otto Bock C-Leg: Amputees' preferred prosthetic knee.", 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prosthetic Knee 2', 'description': 'Otto Bock Genium: Study knee.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '75 Meter Self Selected Walking Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prosthetic Knee 1', 'description': "Otto Bock C-Leg: Amputees' preferred prosthetic knee."}, {'id': 'OG001', 'title': 'Prosthetic Knee 2', 'description': 'Otto Bock Genium: Study knee.'}, {'id': 'OG002', 'title': 'Non Amputee Control Group', 'description': 'healthy, non-amputee controls'}], 'classes': [{'categories': [{'measurements': [{'value': '65.1', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '54.0', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.', 'description': 'Time to Complete a 75 meter walking distance.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Balance and Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prosthetic Knee 1', 'description': "Otto Bock C-Leg: Amputees' preferred prosthetic knee."}, {'id': 'OG001', 'title': 'Prosthetic Knee 2', 'description': 'Otto Bock Genium: Study knee.'}, {'id': 'OG002', 'title': 'Non Amputee Control Group', 'description': 'healthy, non-amputee controls'}], 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '59.2', 'spread': '25.4', 'groupId': 'OG001'}, {'value': '73.1', 'spread': '21.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.', 'description': 'Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prosthesis Evaluation Questionnaire: Utility Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prosthetic Knee 1', 'description': "Otto Bock C-Leg: Amputees' preferred prosthetic knee."}, {'id': 'OG001', 'title': 'Prosthetic Knee 2', 'description': 'Otto Bock Genium: Study knee.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.', 'description': "The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Physical Functional Performance (Continuous Scale; 10-items)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prosthetic Knee 1', 'description': "Otto Bock C-Leg: Amputees' preferred prosthetic knee."}, {'id': 'OG001', 'title': 'Prosthetic Knee 2', 'description': 'Otto Bock Genium: Study knee.'}, {'id': 'OG002', 'title': 'Non Amputee Control Group', 'description': 'healthy, non-amputee control group'}], 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '73.04', 'spread': '15.67', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.', 'description': 'Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prosthetic Knee 1 Then Prosthetic Knee 2', 'description': "Otto Bock C-Leg: Amputees' preferred prosthetic knee then experimental knee (Genium)."}, {'id': 'FG001', 'title': 'Prosthetic Knee 2 Then Prosthetic Knee 1', 'description': "Experimental knee (Otto Bock Genium: Study knee) then subjects' preferred knee (C-Leg)."}, {'id': 'FG002', 'title': 'Control (Non-amputees)', 'description': 'Non-amputee control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': "Includes groups randomized to receive Otto Bock C-Leg (prosthetic knee 1), amputees' preferred prosthetic knee, first and Otto Bock Genium (prosthetic knee 2), the study knee, first."}, {'id': 'BG001', 'title': 'Non Amputee Control Group', 'description': 'non-amputee healty controls'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '51.9', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'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': '18', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2011-05-31', 'resultsFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2011-11-14', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-17', 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '75 Meter Self Selected Walking Test', 'timeFrame': 'Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.', 'description': 'Time to Complete a 75 meter walking distance.'}, {'measure': 'Physical Functional Performance (Continuous Scale; 10-items)', 'timeFrame': 'Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.', 'description': 'Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.'}], 'secondaryOutcomes': [{'measure': 'Balance and Stability', 'timeFrame': 'Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.', 'description': 'Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.'}, {'measure': 'Prosthesis Evaluation Questionnaire: Utility Score.', 'timeFrame': 'Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.', 'description': "The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Other and Unspecified Complications of Amputation Stump']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Unilateral transfemoral or knee-disarticulation amputee\n* 18 to 85 years of age\n* K3 (variable cadence and community) ambulators;\n* Current use of and experience with the C-Leg for at least 1 year\n* Ability to descend stairs and hills without caregiver and assistive devices\n* Be able to independently provide informed consent\n* Be willing to comply with study procedures.\n\nExclusion criteria:\n\n* History of chronic skin breakdown on the residual limb\n* Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)\n* Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate\n* Unwillingness/inability to follow instructions'}, 'identificationModule': {'nctId': 'NCT01473992', 'briefTitle': 'Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis', 'orgStudyIdInfo': {'id': '6140101200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prosthetic knee 1 (Otto Bock C-Leg)', 'description': 'This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics).', 'interventionNames': ['Device: Otto Bock C-Leg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prosthetic knee 2 (Otto Bock Genium)', 'description': 'This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance)', 'interventionNames': ['Device: Otto Bock Genium']}, {'type': 'NO_INTERVENTION', 'label': 'Non-amputee controls', 'description': 'This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.'}], 'interventions': [{'name': 'Otto Bock C-Leg', 'type': 'DEVICE', 'description': "Amputees' preferred prosthetic knee.", 'armGroupLabels': ['Prosthetic knee 1 (Otto Bock C-Leg)']}, {'name': 'Otto Bock Genium', 'type': 'DEVICE', 'description': 'Study knee.', 'armGroupLabels': ['Prosthetic knee 2 (Otto Bock Genium)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'M. Jason Highsmith, PT,DPT,CP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jason Highsmith', 'class': 'OTHER'}, 'collaborators': [{'name': 'Otto Bock Healthcare', 'class': 'INDUSTRY'}, {'name': 'Florida High Tech Corridor Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jason Highsmith', 'investigatorAffiliation': 'University of South Florida'}}}}