Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01379118
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2011-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patient before and after surgery', 'timeFrame': '36 months', 'description': 'To determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. Clinical measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Total knee replacement'], 'conditions': ['Degenerative Joint Disease', 'Osteoarthritis', 'Knee Injury, Trauma', 'Connective Tissue Disorder', 'Pain', 'Loss of Function']}, 'descriptionModule': {'briefSummary': 'This study is to determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients. Gait data will also be obtained from total knee replacement (TKR) patients at pre-operative and post-operative times. Gait data will be measured on unaffected normal controls as a second baseline.\n\nThe hypothesis is that the subjects clinical outcome measures do not accurately reflect gait dependent outcomes amd functional performance of the total knee replacement.', 'detailedDescription': 'Patients scheduled to undergo unilateral total knee replacement (TKR) surgery will be the subjects of the study. A control group of Healthy volunteers, will serve as a control group. The control group will be matched as close as possible by age and gender to the TKR group. Both pre and post-operative (3 weeks, 6, 9 and 12 months follow-up) measurements will be performed on the TKR group.\n\nA Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to record body motion, the sensors for the IDEEA device will be placed on the patient and secured with adhesive tape(if not allergic) once the IDEEA device is properly placed on the patient, measuring and calibrating can start.\n\nThe patient will be required to perform tasks, walking at a normal pace for approximately 100 feet on a level surface, walk up and down moderate incline ramp, climb stairs 7 to 8 steps, sit and rise from two chairs. Parameters will be measured on each subject, knee flexion angle( walking, stair climbing and sitting), velocity ( walking and stair climbing), Stride length (walking), Energy (walking, stair climbing, and sitting), other parameters will be added as needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients that are healthy and patients that need a unilateral total knee replacement.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy\n* needs unilateral total knee replacement\n\nExclusion Criteria:\n\n* Active infection\n* Autoimmune disease/ parkinson's disease\n* HIV\n* psychosocial disorders that would preclude accurate evaluation or substance abuse\n* allergic to\n* pregnant\n* active malignancy"}, 'identificationModule': {'nctId': 'NCT01379118', 'acronym': 'TKR', 'briefTitle': 'Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Comparison of Clinical Scales and Quantitative Knee Motion Data in Assessing the Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery', 'orgStudyIdInfo': {'id': '5110158'}}, 'contactsLocationsModule': {'locations': [{'zip': '92408', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Healthcare, Deptartment of Orthopaedic Surgery', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}], 'overallOfficials': [{'name': 'Gary D. Botimer, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. and Chairman', 'investigatorFullName': 'Gary Botimer', 'investigatorAffiliation': 'Loma Linda University'}}}}