Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05091918
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2021-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Limited Market Release - MotionSense Clinical Use Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kevin.Barga@stryker.com', 'phone': '+12018315073', 'title': 'Kevin Barga', 'organization': 'Stryker'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Comment for Document Section: Initially the Ethical Review Committee did not request a detailed Statistical Analysis Plan. The Statistical Analysis Plan was uploaded to describe the standard analysis for descriptive statics. The study concluded on August 1, 2022. Therefore, belated IRB approval of the standard statistical analysis plan was not requested.'}}, 'adverseEventsModule': {'timeFrame': '30 days pre-op until 90 days post-op', 'eventGroups': [{'id': 'EG000', 'title': 'Motionsense Wearable Group', 'description': 'Using Motionsense from up to 30 days pre-op and 90 days post-op during the recovery after primary TKA\n\nMotionsense Wearable: Remote patient monitoring', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 10, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Deep joint infection', 'notes': 'Bacterial infection was the result of a plastic surgery. Source was plastic surgery, not the total knee SURGERY.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Knee stiffness Arthrofibrosis', 'notes': 'Pain and stiffness requiring manipulation under anesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative.', 'reportingStatus': 'POSTED', 'populationDescription': 'The office staff did not collect data on the hours spent per day in office, except for onboarding time, which is Outcome Measure 5.'}, {'type': 'PRIMARY', 'title': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'title': 'Preoperative day of initial use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12', 'groupId': 'OG000', 'lowerLimit': '-14', 'upperLimit': '-7'}]}]}, {'title': 'Preoperative day of last use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '-1'}]}]}, {'title': 'Postoperative day of initial use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Postoperative day of last use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative', 'unitOfMeasure': 'Days relative to surgery', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Preoperative participants: 2 Patients did not wear device preoperatively. Postoperative participants: 23 Patients did not wear device postoperatively.'}, {'type': 'PRIMARY', 'title': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'title': 'Preoperative questionnaire', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Postoperative 2 week questionnaire', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Postoperative 6 week questionnaire', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Postoperative 90 day questionnaire', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative', 'description': 'Count of participants who have completed the aggregate questionnaires in the MotionSense App downloaded to their mobile devices at each timepoint for evaluation of compliance with the MotionSense Wearable System.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Percent of exercise sessions completed while wearing MotionSense from 30 days preoperative to 90 days postoperative.\n\nAn exercise session is a collection of exercises that can be customized and assigned to a patient to be performed either once or twice a day.', 'unitOfMeasure': 'Percent of completed exercise sessions', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 10 patients who did not have any exercise data that was completed.'}, {'type': 'PRIMARY', 'title': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative onboarding visit', 'description': 'Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 7 patients who did not have onboarding time data collected.'}, {'type': 'PRIMARY', 'title': 'Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'title': 'Pre-op: Isometric quads', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '68'}]}]}, {'title': 'Pre-op: Sit-to-stands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pre-op: Short-arc quads', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '68'}]}]}, {'title': 'Pre-op: Heel slides', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '67'}]}]}, {'title': 'Pre-op: Hamstring curls', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pre-op: Long-arc quads', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pre-op: Straight-leg raises', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}]}]}, {'title': 'Pre-op: Standing knee bends', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pre-op: Knee straightening stretches', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '68'}]}]}, {'title': 'Pre-op: Sitting knee bends', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Pre-op: Assisted knee stretches', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': 'Pre-op: Warmup', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '68'}]}]}, {'title': '0-30 days post-op: Isometric quads', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '91'}]}]}, {'title': '0-30 days post-op: Sit-to-stands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': '0-30 days post-op: Short-arc quads', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '91'}]}]}, {'title': '0-30 days post-op: Heel slides', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '90'}]}]}, {'title': '0-30 days post-op: Hamstring curls', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '0-30 days post-op: Long-arc quads', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '20'}]}]}, {'title': '0-30 days post-op: Straight-leg raises', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '20'}]}]}, {'title': '0-30 days post-op: Standing knee bends', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '18'}]}]}, {'title': '0-30 days post-op: Knee straightening', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '91'}]}]}, {'title': '0-30 days post-op: Sitting knee bends', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '13'}]}]}, {'title': '0-30 days post-op: Assisted knee stretches', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '7'}]}]}, {'title': '0-30 days post-op: Warm', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '91'}]}]}, {'title': '31-60 days post-op: Isometric quads', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '70'}]}]}, {'title': '31-60 days post-op: Sit-to-stands', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '26'}]}]}, {'title': '31-60 days post-op: Short-arc quads', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '70'}]}]}, {'title': '31-60 days post-op: Heel slides', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '74'}]}]}, {'title': '31-60 days post-op: Hamstring curls', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '14'}]}]}, {'title': '31-60 days post-op: Long-arc quads', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '28'}]}]}, {'title': '31-60 days post-op: Straight-leg raises', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '31'}]}]}, {'title': '31-60 days post-op: Standing knee bends', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '28'}]}]}, {'title': '31-60 days post-op: Knee straightening', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '70'}]}]}, {'title': '31-60 days post-op: Sitting knee bends', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '22'}]}]}, {'title': '31-60 days post-op: Assisted knee stretches', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '16'}]}]}, {'title': '31-60 days post-op: Warmup', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '75'}]}]}, {'title': '61-90 days post-op: Isometric quads', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '57'}]}]}, {'title': '61-90 days post-op: Sit-to-stands', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '30'}]}]}, {'title': '61-90 days post-op: Short-arc quads', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '58'}]}]}, {'title': '61-90 days post-op: Heel slides', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '65'}]}]}, {'title': '61-90 days post-op: Hamstring curls', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '17'}]}]}, {'title': '61-90 days post-op: Long-arc quads', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '30'}]}]}, {'title': '61-90 days post-op: Straight-leg raises', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '30'}]}]}, {'title': '61-90 days post-op: Standing knee bends', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '27'}]}]}, {'title': '61-90 days post-op: Knee straightening', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '58'}]}]}, {'title': '61-90 days post-op: Sitting knee bends', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '21'}]}]}, {'title': 'Assisted knee stretches', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '16'}]}]}, {'title': '61-90 days post-op: Warmup', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative', 'description': 'Daily percentage of patients prescribed each home exercise during preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative time periods.\n\nIsometric quads: Lie back to floor, tense quadriceps, hold, repeat. Sit-to-stands: Sit, stand, strengthen, repeat. Short-arc quadriceps: Lie back to floor with leg bent, extend leg, hold, repeat.\n\nHeel slides: Lie back to floor, slide and bend leg, hold, repeat. Hamstring curls: Lie stomach to floor, bend leg, hold, repeat. Long-arc quadriceps: Sit, lift, hold, count, repeat, strengthen. Straight leg raises: Lie back to floor, lift leg, hold, lower, repeat. Standing knee bends: Stand, squat, knees, lower, maintain form, repeat. Knee straightening stretches: Lie back to floor, extend leg, tense, relax. Sitting knee bends: Sit, hold, stretch, hold, slide, repeat. Assisted knee stretches: Sit, bend, hold, release, repeat. Warmup: 5 minutes', 'unitOfMeasure': 'Percent of participants assigned', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlate Functional and Patient Reported Outcome Metrics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'title': 'KOOS: ADL, 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: ADL, 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: ADL, 90 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Pain, 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Pain, 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Pain, 90 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: QoL, 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: QoL, 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: QoL, 90 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Sport/Recreation, 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Sport/Recreation, 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Sport/Recreation, 90 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Symptoms, 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Symptoms, 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000'}]}]}, {'title': 'KOOS: Symptoms, 90 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks, 6 weeks, 90 days postoperative', 'description': 'Spearman correlation of mean step count to Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire.\n\nThe Statistical Spearman correlation coefficient evaluates relationships between variables. The Spearman correlation coefficient is used to evaluate the relationship of the mean step count to the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The KOOS consists of 5 subscales: Pain, other symptoms, function in daily living (ADL), function in sport and recreation and knee related quality of life (QOL).\n\nThe Spearman Correlation coefficients range from -1to 1. If r = 0, there is no linear relationship between the variables. If r=+1, there is a strong direct relationship. If r = -1, there is a strong inverse relationship.', 'unitOfMeasure': 'Spearman Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'At 2 weeks (-5 days), 60 patients did not have completed data for KOOS or step count.\n\nAt 6 weeks (-5 days), 61 patients did not have completed data for KOOS or step count.\n\nAt 90 days (-5 days), 90 patients did not have completed data for KOOS or step count.'}, {'type': 'SECONDARY', 'title': 'Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Motionsense Wearable Group', 'description': 'Using Motionsense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Number of leg registrations performed (per day) per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of leg registrations performed per day per patient was not collected. These data collections were not technically feasible.'}, {'type': 'SECONDARY', 'title': 'Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Motionsense Wearable Group', 'description': 'Using Motionsense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Number of weekly and daily patches used per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of weekly and daily patches used per patient was not collected. Accurate data collection was unattainable by office staff.'}, {'type': 'SECONDARY', 'title': 'Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Total number of wound pictures shared with surgeon office per patient while wearing MotionSense from 30 days preoperative to 90 days postoperative', 'unitOfMeasure': 'Shared pictures', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Visual Analog Scale (VAS) pain scores while wearing MotionSense from 30 days preoperative to 90 days postoperative\n\nThe VAS pain score is a patient questionnaire to assess the subjective pain intensity. The VAS is a horizontal line ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 patients were not included in the analysis because they did not produce pain scores.'}, {'type': 'SECONDARY', 'title': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '2519', 'groupId': 'OG000', 'lowerLimit': '886', 'upperLimit': '4771'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Daily steps while wearing MotionSense from 30 days preoperative to 90 days postoperative', 'unitOfMeasure': 'Daily steps', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 4 patients who did not produce daily steps or wear device for longer than 10 minutes per day.'}, {'type': 'SECONDARY', 'title': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'title': 'Weight bearing time', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '214'}]}]}, {'title': 'Knee active time', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '94'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative\n\nKnee active time is the time the patient spends moving the knee per day. Weight bearing time is the time the patient spends with the leg in an upright position per day.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 4 patients who did not produce knee active or weight bearing time, or wear the device for greater than 10 minutes per day.'}, {'type': 'SECONDARY', 'title': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '120'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative\n\nRange of Motion (ROM) for the knee refers to the degree of movement that can be achieved at the knee joint. It describes the arc or extent of motion from full extension (straightening) to full flexion (bending) in degrees.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 12 patients who did not produce ROM data, wear the device for long enough (\\>10 mins/day), or were excluded due to data quality concerns.'}, {'type': 'SECONDARY', 'title': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MotionSense Wearable Group', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Steps per minute while wearing MotionSense from 30 days preoperative to 90 days postoperative', 'unitOfMeasure': 'Steps per minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Gait analysis was incomplete for 16 patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Motionsense Wearable Group', 'description': 'Using Motionsense from pre-op to 90 days post-op during the recovery after primary TKA\n\nMotionsense Wearable: Remote patient monitoring'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Motionsense Wearable Group', 'description': 'Using Motionsense from up to 30 days pre-op and 90 days post-op during the recovery after primary TKA\n\nMotionsense Wearable: Remote patient monitoring'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'Other/Multiple', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Declined to respond', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-15', 'size': 410450, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-18T11:17', 'hasProtocol': True}, {'date': '2023-05-18', 'size': 116806, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-18T11:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2021-10-13', 'resultsFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-13', 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative.'}, {'measure': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative'}, {'measure': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires', 'timeFrame': 'Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative', 'description': 'Count of participants who have completed the aggregate questionnaires in the MotionSense App downloaded to their mobile devices at each timepoint for evaluation of compliance with the MotionSense Wearable System.'}, {'measure': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Percent of exercise sessions completed while wearing MotionSense from 30 days preoperative to 90 days postoperative.\n\nAn exercise session is a collection of exercises that can be customized and assigned to a patient to be performed either once or twice a day.'}, {'measure': 'Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic', 'timeFrame': 'Preoperative onboarding visit', 'description': 'Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation.'}, {'measure': 'Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists', 'timeFrame': 'Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative', 'description': 'Daily percentage of patients prescribed each home exercise during preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative time periods.\n\nIsometric quads: Lie back to floor, tense quadriceps, hold, repeat. Sit-to-stands: Sit, stand, strengthen, repeat. Short-arc quadriceps: Lie back to floor with leg bent, extend leg, hold, repeat.\n\nHeel slides: Lie back to floor, slide and bend leg, hold, repeat. Hamstring curls: Lie stomach to floor, bend leg, hold, repeat. Long-arc quadriceps: Sit, lift, hold, count, repeat, strengthen. Straight leg raises: Lie back to floor, lift leg, hold, lower, repeat. Standing knee bends: Stand, squat, knees, lower, maintain form, repeat. Knee straightening stretches: Lie back to floor, extend leg, tense, relax. Sitting knee bends: Sit, hold, stretch, hold, slide, repeat. Assisted knee stretches: Sit, bend, hold, release, repeat. Warmup: 5 minutes'}], 'secondaryOutcomes': [{'measure': 'Correlate Functional and Patient Reported Outcome Metrics', 'timeFrame': '2 weeks, 6 weeks, 90 days postoperative', 'description': 'Spearman correlation of mean step count to Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire.\n\nThe Statistical Spearman correlation coefficient evaluates relationships between variables. The Spearman correlation coefficient is used to evaluate the relationship of the mean step count to the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The KOOS consists of 5 subscales: Pain, other symptoms, function in daily living (ADL), function in sport and recreation and knee related quality of life (QOL).\n\nThe Spearman Correlation coefficients range from -1to 1. If r = 0, there is no linear relationship between the variables. If r=+1, there is a strong direct relationship. If r = -1, there is a strong inverse relationship.'}, {'measure': 'Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Number of leg registrations performed (per day) per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.'}, {'measure': 'Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Number of weekly and daily patches used per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.'}, {'measure': 'Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Total number of wound pictures shared with surgeon office per patient while wearing MotionSense from 30 days preoperative to 90 days postoperative'}, {'measure': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Visual Analog Scale (VAS) pain scores while wearing MotionSense from 30 days preoperative to 90 days postoperative\n\nThe VAS pain score is a patient questionnaire to assess the subjective pain intensity. The VAS is a horizontal line ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.'}, {'measure': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Daily steps while wearing MotionSense from 30 days preoperative to 90 days postoperative'}, {'measure': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative\n\nKnee active time is the time the patient spends moving the knee per day. Weight bearing time is the time the patient spends with the leg in an upright position per day.'}, {'measure': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative\n\nRange of Motion (ROM) for the knee refers to the degree of movement that can be achieved at the knee joint. It describes the arc or extent of motion from full extension (straightening) to full flexion (bending) in degrees.'}, {'measure': 'Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute)', 'timeFrame': '30 days preoperative to 90 days postoperative', 'description': 'Steps per minute while wearing MotionSense from 30 days preoperative to 90 days postoperative'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['MotionSense'], 'conditions': ['Knee Arthroplasty', 'Patient Engagement', 'Patient-Reported Outcome Measures (PROMs)']}, 'descriptionModule': {'briefSummary': 'Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.', 'detailedDescription': 'During the proposed study, the MotionSense wearable system will be used by patients undergoing total knee arthroplasty (TKA) surgery leading up to and after their surgery. The patients will be using the system to monitor their recovery during daily activities, log daily pain scores and patient reported outcomes while also supporting their prescribed home exercise program. Each patient will thereby participate in outpatient physiotherapy in line with their current standard of care, while the physiotherapist will leverage the opportunities of the presented platform to give the patient personalized reminders for their patient-specific home exercise program. The surgeon / research nurse will additionally be able to monitor the patients recovery remotely as the sensor / app data is shared to the OrthoLogIQ platform.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned for unilateral total knee surgery in the coming 4 weeks\n* Age 50 to 80\n* Owns a smart phone\n\nExclusion Criteria:\n\n* BMI exceeding 35\n* Severe skin conditions'}, 'identificationModule': {'nctId': 'NCT05091918', 'acronym': 'FS5', 'briefTitle': 'Limited Market Release - MotionSense Clinical Use Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orthosensor, Inc.'}, 'officialTitle': 'FS5 Limited Market Release - MotionSense Clinical Use Evaluation', 'orgStudyIdInfo': {'id': 'Orthosensor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MotionSense Wearable', 'description': 'Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA', 'interventionNames': ['Device: MotionSense']}], 'interventions': [{'name': 'MotionSense', 'type': 'DEVICE', 'description': 'MotionSense Wearable: Remote patient monitoring', 'armGroupLabels': ['MotionSense Wearable']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73114', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Joint Reconstruction Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '02879', 'city': 'Wakefield', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Robotic Joint Replacement Institute LLC', 'geoPoint': {'lat': 41.43732, 'lon': -71.50145}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthosensor, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}