Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-01 @ 8:39 AM
Study NCT ID:
NCT03562559
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2018-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Skin to Adductor Canal Distance in Various Positions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marcus.tholin@vch.ca', 'phone': '604-875-4111', 'title': 'Marcus Tholin', 'organization': 'Vancouver General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event date was not collected since this was an observational study', 'description': 'There was no opportunity for adverse event since the object of the study was ultrasound measurements of anatomy.', 'eventGroups': [{'id': 'EG000', 'title': 'TKA Patients', 'description': 'Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skin to Adductor Canal Distance Disparity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TKA Patients', 'description': 'Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.'}], 'classes': [{'title': 'Neutral vs manual displacement distance (cm)', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.20'}]}]}, {'title': 'Neutral vs external rotation distance (cm)', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.39'}]}]}, {'title': 'Neutral vs straight leg raise distance (cm)', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.57'}]}]}, {'title': 'Neutral vs leg flexion distance (cm)', 'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.79'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measurements will be made on the day of surgery, no other assessment or follow up needed', 'description': 'The largest distance disparity as measured from the 5 different leg positions', 'unitOfMeasure': 'centimeters', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TKA Patients', 'description': 'Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients older than 18 years of age undergoing elective total knee arthroplasty who were able to give informed consent'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TKA Patients', 'description': 'Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', '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': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-15', 'size': 74054, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-15T16:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2018-05-29', 'resultsFirstSubmitDate': '2019-01-05', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-24', 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin to Adductor Canal Distance Disparity', 'timeFrame': 'Measurements will be made on the day of surgery, no other assessment or follow up needed', 'description': 'The largest distance disparity as measured from the 5 different leg positions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Adductor Canal Block'], 'conditions': ['Knee Arthritis']}, 'referencesModule': {'references': [{'pmid': '32385824', 'type': 'DERIVED', 'citation': 'Tholin M, Wilson J, Lee S, Tang R, Sawka A, Vaghadia H. Impact of leg movement on skin-adductor canal distance: a potential cause for catheter tip displacement? Can J Anaesth. 2020 Aug;67(8):936-941. doi: 10.1007/s12630-020-01693-6. Epub 2020 May 8.'}]}, 'descriptionModule': {'briefSummary': "To control pain after total knee replacement surgery a catheter (tubing) is sometimes inserted into an anatomic space containing nerves that provide sensation to parts of the knee. This space is called the adductor canal.\n\nThe catheters often stop working before we remove them for unclear reasons. The investigators think this is because the catheters become dislodged from where it was meant to be. This could be due to repeated movements of the catheter tip brought on by patients contracting their leg muscles when they ambulate or perform physio.\n\nThe investigators want to confirm this by measuring the distance from a fixed spot on the patient's thigh to the adductor canal using an ultrasound machine. The leg will be measured in various positions to simulate muscle movements. A significant change in the distance could possibly contribute to catheter dislodgement and result in catheter failure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We are recruiting patients undergoing total knee replacement. Per hospital protocol, patients will receive a spinal anesthetic and adductor canal block as part of their anesthetic regimen. After surgery, previously consented patients will have their skin to adductor canal distance measured by ultrasound in 5 different positions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent\n* Patients must be undergoing a primary total knee arthroplasty with neuraxial anaesthesia\n\nExclusion Criteria:\n\n* Patients with an allergy to ultrasound transducer gel or measuring tape'}, 'identificationModule': {'nctId': 'NCT03562559', 'acronym': 'Skin to AC', 'briefTitle': 'Skin to Adductor Canal Distance in Various Positions', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Impact of Leg Movement on the Skin to Adductor Canal Distance: a Potential Cause for Catheter Displacement?', 'orgStudyIdInfo': {'id': 'H17-02633'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TKA Patients', 'interventionNames': ['Other: Measurements Using Ultrasound']}], 'interventions': [{'name': 'Measurements Using Ultrasound', 'type': 'OTHER', 'description': 'Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.', 'armGroupLabels': ['TKA Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 2B5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Jason Wilson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marcus Tholin', 'investigatorAffiliation': 'University of British Columbia'}}}}