Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-26 @ 5:06 PM
Study NCT ID:
NCT06655558
Status:
TERMINATED
Last Update Posted:
2025-09-04
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validating the Clinical Effect of a Knee Orthosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emartin@topmed.ca', 'phone': '418 683-2104', 'title': 'Edith Martin', 'phoneExt': '1302', 'organization': 'Topmed'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 365 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Targeted enrollement of 30 participants was not reached. Interpretations should be taken with caution because of the small number of participants.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected throughout the full duration of the protocol for each participant, therfore 8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Medial Gonarthrosis', 'description': 'Patients with medial gonarthrosis\n\ncustom knee orthosis: The custom knee orthosis will be worn for 8 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in WOMAC Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medial Gonarthrosis', 'description': 'Patients with medial gonarthrosis\n\ncustom knee orthosis: The custom knee orthosis will be worn for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 8 weeks of intervention(Day 56)', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 24 item questionnaire about knee pain, stiffness and function. Each item uses a 5 point scale ranging from 0 (no pain, stiffness or difficulty) to 4 (extreme pain, stiffness or difficulty). Total score is the sum of all items and ranges from 0 to 96. Therefore low scores represent better knee health whereas high scores represent worse knee health. Change is calculated as :\n\nChange= Score after 8 weeks of treatment - Baseline Score', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in WOMAC Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medial Gonarthrosis', 'description': 'Patients with medial gonarthrosis\n\ncustom knee orthosis: The custom knee orthosis will be worn for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 8 weeks of intervention(Day 56)', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subcore of 5 items about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Pain score is the sum of all 5 items, ranges from 0 to 20. Therefore low scores represent better knee pain whereas high scores represent worse knee pain. Change is calculated as :\n\nChange= Score after 8 weeks of treatment - Baseline Score', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in WOMAC Stiffness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medial Gonarthrosis', 'description': 'Patients with medial gonarthrosis\n\ncustom knee orthosis: The custom knee orthosis will be worn for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 8 weeks of intervention(Day 56)', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 2 items about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Stiffness score is the sum of 2 items, ranges from 0 to 8. Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness. Change is calculated as :\n\nChange= Score after 8 weeks of treatment - Baseline Score', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in WOMAC Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medial Gonarthrosis', 'description': 'Patients with medial gonarthrosis\n\ncustom knee orthosis: The custom knee orthosis will be worn for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 8 weeks of intervention(Day 56)', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 17 items about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Functionnal limitation score is the sum of all 17 items, ranges from 0 to 68. Therefore low scores represent better knee function whereas high scores represent worse knee function. Change is calculated as :\n\nChange= Score after 8 weeks of treatment - Baseline Score', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medial Gonarthrosis', 'description': 'Patients with medial gonarthrosis\n\ncustom knee orthosis: The custom knee orthosis will be worn for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants with medial gonarthosis', 'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants with medial gonarthosis', 'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Medial Gonarthrosis', 'description': 'Patients with medial gonarthrosis\n\ncustom knee orthosis: The custom knee orthosis will be worn for 8 weeks.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18<age<75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants aged between 18 and 75 years old inclusively.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'WOMAC Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) 24 item questionnaire about knee pain, stiffness and function. Each item uses a 5 point scale ranging from 0 (no pain, stiffness or difficulty) to 4 (extreme pain, stiffness or difficulty). Total score is the sum of all items and ranges from 0 to 96. Therefore low scores represent better knee health whereas high scores represent worse knee health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC Pain score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) subcore of 5 items about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Pain score is the sum of all 5 items, ranges from 0 to 20. Therefore low scores represent better knee pain whereas high scores represent worse knee pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC Stiffness Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 2 items about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Stiffness score is the sum of 2 items, ranges from 0 to 8. Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC Physical Function Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 17 items about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Physical function score is the sum of all 17 items, ranges from 0 to 68. Therefore low scores represent better knee function whereas high scores represent worse knee function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2024-05-08', 'size': 303083, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T16:08', 'hasProtocol': True}, {'date': '2024-05-08', 'size': 299859, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-06T16:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Longitudal treatment validation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Budget for the research project ran out.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2024-10-21', 'resultsFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-31', 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in WOMAC Total Score', 'timeFrame': 'At baseline and after 8 weeks of intervention(Day 56)', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 24 item questionnaire about knee pain, stiffness and function. Each item uses a 5 point scale ranging from 0 (no pain, stiffness or difficulty) to 4 (extreme pain, stiffness or difficulty). Total score is the sum of all items and ranges from 0 to 96. Therefore low scores represent better knee health whereas high scores represent worse knee health. Change is calculated as :\n\nChange= Score after 8 weeks of treatment - Baseline Score'}, {'measure': 'Change in WOMAC Pain Score', 'timeFrame': 'At baseline and after 8 weeks of intervention(Day 56)', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subcore of 5 items about knee pain. Each item uses a 5 point scale ranging from 0 (no pain) to 4 (extreme pain). Pain score is the sum of all 5 items, ranges from 0 to 20. Therefore low scores represent better knee pain whereas high scores represent worse knee pain. Change is calculated as :\n\nChange= Score after 8 weeks of treatment - Baseline Score'}, {'measure': 'Change in WOMAC Stiffness Score', 'timeFrame': 'At baseline and after 8 weeks of intervention(Day 56)', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 2 items about knee stiffness. Each item uses a 5 point scale ranging from 0 (no stiffness) to 4 (extreme stiffness). Stiffness score is the sum of 2 items, ranges from 0 to 8. Therefore low scores represent better knee stiffness whereas high scores represent worse knee stiffness. Change is calculated as :\n\nChange= Score after 8 weeks of treatment - Baseline Score'}, {'measure': 'Change in WOMAC Physical Function Score', 'timeFrame': 'At baseline and after 8 weeks of intervention(Day 56)', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore of 17 items about knee function. Each item uses a 5 point scale ranging from 0 (no dificulty) to 4 (extreme dificulty). Functionnal limitation score is the sum of all 17 items, ranges from 0 to 68. Therefore low scores represent better knee function whereas high scores represent worse knee function. Change is calculated as :\n\nChange= Score after 8 weeks of treatment - Baseline Score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee orthosis', 'knee brace', 'validation', 'WOMAC', 'knee pain', 'knee stiffness', 'daily activities', 'knee function'], 'conditions': ['Medial Gonarthrosis']}, 'descriptionModule': {'briefSummary': "The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem.\n\nKnee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms.\n\nParticipants answered a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire before receiving their custom knee brace(Baseline) and after 8 weeks (56 days) of treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suffering from medial gonarthrosis\n* Receiving a regular model of the O3D orthosis\n\nExclusion Criteria:\n\n* Suffering from tricompartmental gonarthosis\n* Having completed the delivery appointment for a O3D orthosis'}, 'identificationModule': {'nctId': 'NCT06655558', 'briefTitle': 'Validating the Clinical Effect of a Knee Orthosis', 'organization': {'class': 'OTHER', 'fullName': 'TOPMED'}, 'officialTitle': 'Validating the Clinical Effect of a Knee Orthosis', 'orgStudyIdInfo': {'id': '241_O3D_Quest'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'medial gonarthrosis', 'description': 'Patients with medial gonarthrosis', 'interventionNames': ['Device: custom knee orthosis']}], 'interventions': [{'name': 'custom knee orthosis', 'type': 'DEVICE', 'description': 'The custom knee orthosis will be worn for 8 weeks (56 days).', 'armGroupLabels': ['medial gonarthrosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1S1C1', 'city': 'Québec', 'country': 'Canada', 'facility': 'Topmed', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Edith Martin, Phd.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TOPMED'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TOPMED', 'class': 'OTHER'}, 'collaborators': [{'name': 'Natural Sciences and Engineering Research Council, Canada', 'class': 'OTHER'}, {'name': 'O3D inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}