Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-18 @ 8:39 AM
Study NCT ID:
NCT03673293
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2018-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Postoperative Mobility, Gait Symmetry and Feedback Following TJA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Vertical Ground Reaction Forces (vGRF)', 'timeFrame': '6-weeks', 'description': 'Gait analysis of vertical ground reaction forces generated while performing routine exercises'}, {'measure': 'Peak Vertical Ground Reaction Forces (vGRF)', 'timeFrame': '6-months', 'description': 'Gait analysis of vertical ground reaction forces generated while performing'}, {'measure': 'Peak Vertical Ground Reaction Forces (vGRF)', 'timeFrame': '12-months', 'description': 'Gait analysis of vertical ground reaction forces generated while performing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Joint Arthroplasty', 'Postoperative mobility', 'Gait symmetry', 'Feedback'], 'conditions': ['Total Joint Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are:\n\n1. The investigators plan to evaluate and validate the use of a novel wireless insole device (Loadsol) that provides real-time biofeedback on post-operative mobility and weight bearing following total joint arthroplasty.\n2. The investigators plan to utilize the wireless insole device to determine if biofeedback is sufficient for improving gait symmetry following total joint arthroplasty.\n3. The investigators plan to determine if there is a correlation between patient reported outcomes and measured postoperative weight bearing.', 'detailedDescription': 'In orthopaedic and trauma surgery post-operative mobility is very important. Six-month mortality and patient satisfaction has been associated with mobility. Elderly patients may suffer from severe complications caused by immobility due to a high prevalence of comorbidities.\n\nMeasuring postoperative mobility has primarily been based on advanced technology and complicated gait laboratories (treadmill, force plate, videoanalysis). The recent introduction of mobile insole force devices, such as the pedoped loadsol® (Novel) may allow for a cost-effective and clinically relevant use of providing biofeedback.\n\nUsing video analysis to evaluate the insole device will allow for measurements in realistic situations like walking stairs, stand up from a chair, sit down, turning and walking. The investigators had previously completed this in the lab setting and further the feedback mode of the loadsol will be used for training the patients in terms of symmetry after a total knee replacement.\n\nThis study may have an important influence on the aftercare of the investigators patients. Determining the postoperative mobility and evaluating gait analysis in real time will allow the investigators to compare between different operative approaches, operative techniques, Implants and more. If the feedback mode is working as expected the investigators might use it in the close future in the investigators standard aftercare for all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who plan or recently underwent (up to 8 weeks postoperatively) primary total joint arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned or recently underwent (up to 8 weeks postoperatively) primary total joint arthroplasty\n* Free walking before surgery, no devices needed\n* Age \\>/=18 years\n* Preoperative outcomes scores (PF CAT, PROMIS Global Health, KOOS JR)\n* Written informed consent\n\nExclusion Criteria:\n\n* Index procedure is a revision total joint arthroplasty\n* Total knee or hip arthroplasty on the contralateral side within 1 one year of index procedure\n* Severe medical comorbidity (ASA\\>/=3)\n* Participant is planning TJA on another joint within next 12 months\n* Significant symptoms on contralateral knee/hip/ankle that could impede performance on study'}, 'identificationModule': {'nctId': 'NCT03673293', 'briefTitle': 'Measuring Postoperative Mobility, Gait Symmetry and Feedback Following TJA', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Measuring Postoperative Mobility, Gait Symmetry and Feedback With New Technology Following Total Joint Arthroplasty', 'orgStudyIdInfo': {'id': '110935'}}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Orthopaedic Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Christopher Pelt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Christopher Pelt', 'investigatorAffiliation': 'University of Utah'}}}}