Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT05693818
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limp Severity', 'timeFrame': '4-6 wks+3 days weeks post TKA', 'description': "The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe)."}], 'secondaryOutcomes': [{'measure': 'Test-retest reliability of the Canary Medical Limping Model (CMLM) score', 'timeFrame': '4-6 wks+3 days weeks post TKA', 'description': 'Test-retest reliability of the CMLM score from day-to-day and week-to-week. (Specific days and weeks will be provided in the Statistical Analysis Plan.)'}, {'measure': "Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment", 'timeFrame': '4-6 wks+3 days weeks post TKA', 'description': 'Positive Percent Agreement (PPA)'}, {'measure': "Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment", 'timeFrame': '4-6 wks+3 days weeks post TKA', 'description': 'Negative Percent Agreement (NPA)'}, {'measure': 'Knee Range of Motion', 'timeFrame': '4-6 wks+3 days weeks post TKA', 'description': 'ROM will be measured by a goniometer'}, {'measure': 'Numeric Pain Rating Scale', 'timeFrame': '4-6 wks+3 days weeks post TKA', 'description': 'Subjective Pain Measurement'}, {'measure': 'KOOS Jr', 'timeFrame': '4-6 wks+3 days weeks post TKA', 'description': 'Patient Reported outcome'}, {'measure': 'Limping Self Evaluation', 'timeFrame': '4-6 wks+3 days weeks post TKA', 'description': 'Study participants will be asked the following question, "During the past week, have you been limping when walking, because of your knee?" The following answers will be allowed:\n\n* Rarely / never\n* Sometimes or just at first, after sitting for a long time\n* Often, not just at first\n* Most of the time\n* All of the time'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'PersonaIQ'], 'conditions': ['Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.', 'detailedDescription': "The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients indicated for a commercially available PIQ TKA implant who meet the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patient must be 18 years of age or older\n\n * Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling\n * Patient must be willing and able to complete the protocol required follow-up\n * Patient has participated in the study-related informed consent process\n * Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent\n\nExclusion Criteria:\n\n* • Simultaneous bilateral TKA\n\n * Staged bilateral TKA less than 6 months from indexed procedure\n * Patient is a current alcohol or drug abuser\n * Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)\n * Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program\n * Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions\n * Patient with Neuropathic Arthropathy\n * Patient with any loss of musculature or neuromuscular disease that compromises the affected limb\n * Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait'}, 'identificationModule': {'nctId': 'NCT05693818', 'briefTitle': 'Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Canary Medical'}, 'officialTitle': 'A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension', 'orgStudyIdInfo': {'id': 'POS-CTE-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PersonaIQ', 'description': 'Patients indicated for a PersonaIQ total knee arthroplasty', 'interventionNames': ['Other: Clinical Limping Evalution']}], 'interventions': [{'name': 'Clinical Limping Evalution', 'type': 'OTHER', 'otherNames': ['Limp Detection'], 'description': "Patients will be asked to perform a Clinical Limping Evaluation in the clinic during their post-operative follow-up visit. This will be performed in a controlled environment within the physician's clinic. Each patient will be asked to walk at their normal walking speed down a hallway for at least 7 consecutive steps and back toward the physician. Walking down the hallway and back is one walking trial. Each patient will be asked to perform 2 walking trials. The health care provider will assess the patient's limp using a 3-point Likert scale (0=No limp, 1=mild/moderate limp, 2=severe limp).\n\nIf required, patients may use an assistive device and the type of device should be documented. If a patient requires assistance, only the minimum amount of assistance required for a patient to complete the task should be provided.", 'armGroupLabels': ['PersonaIQ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Gerscovich, MD', 'role': 'CONTACT', 'phone': '864-582-6396'}, {'name': 'Daniel Gerscovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carolina Orthopaedic & Neurosurgical Associates', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}], 'centralContacts': [{'name': 'Derek E. Coulter', 'role': 'CONTACT', 'email': 'dcoulter@canarymedical.com', 'phone': '18066816979'}, {'name': 'Nora York', 'role': 'CONTACT', 'email': 'nyork@canarymedical.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canary Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}