Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-06 @ 1:29 AM
Study NCT ID:
NCT01814033
Status:
UNKNOWN
Last Update Posted:
2015-10-09
First Post:
2013-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2013-03-15', 'studyFirstSubmitQcDate': '2013-03-18', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Function', 'timeFrame': '3 Days', 'description': 'Functional parameters of bed mobility, transfers, ambulation, gait, and stair climbing will be assessed daily using standard measures used in physical therapy assessment( dependent, moderate assist of one or two, minimal assist of one or two, hands on supervision, stand by supervision, or independence. )'}], 'primaryOutcomes': [{'measure': 'Range of Motion', 'timeFrame': '3 Days', 'description': 'Knee ROM measured both actively and passively with a standard long arm goniometer twice daily for both groups.'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '3 Days', 'description': 'Pain will be assessed using a visual analogue scale twice daily both at rest and with activity (exercise).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LRU', 'Total Knee Arthroplasty', 'Total Knee Replacement', 'Acute Rehabilitation Total Knee', 'Total Knee Range of Motion', 'Total Knee Acute care Outcomes'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '23451469', 'type': 'BACKGROUND', 'citation': 'Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44.'}]}, 'descriptionModule': {'briefSummary': 'The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or function for a group of patients following total knee arthroplasty (TKA) who use the LRU pillow as compared to a control group of total knee arthroplasty patients who do not use the pillow.', 'detailedDescription': '1. Study design will be a Pretest-Posttest Control Group Design . Enrollment would be random assignment of 20 patients to a control group vs 20 patients to a treatment group for patients with the diagnosis of osteoarthritis (OA) of the knee admitted for primary total knee arthroplasty. For specifics of patient assignment, please see below under Recruitment Procedures.\n2. Unpaired t-Tests will be used to determine differences between mean scores for the dependent variables (pain, range of motion, functional mobility). Analysis of Covariance will be run to quantify the effect of the co-variates of age, gender, body mass index (BMI), and contralateral previous TKA. Confidence Intervals will be set at 95%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis.\n\nExclusion criteria:\n\n* bilateral total knee arthroplasties\n* revision total knee arthroplasties\n* unexpected decline in medical or mental status\n* Subjects will range from 30 years of age to 80 years of age\n* primary diagnosis of rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT01814033', 'acronym': 'LRU', 'briefTitle': 'Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Newton-Wellesley Hospital'}, 'officialTitle': 'Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'LRU1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LRU Pillow', 'description': 'Experimental: LRU Pillow', 'interventionNames': ['Other: Experimental: LRU Pillow']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Other: Control Group', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Experimental: LRU Pillow', 'type': 'OTHER', 'description': 'Foam wedge with a trough for positioning of the lower leg in an elevated position.', 'armGroupLabels': ['LRU Pillow']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Standard bed pillows placed under the lower leg to facilitate elevation', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02462', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Hope M Violette, BS', 'role': 'CONTACT', 'email': 'hviolette1@partners.org', 'phone': '617-243-6493'}, {'name': 'Theresa J Gustus, PT, MS, DPT', 'role': 'CONTACT', 'email': 'tgustus@partners.org', 'phone': '617-243-6885'}, {'name': 'Theresa J Gustus, PT, DPT, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David A Nicoloro, PT, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Newton Wellesley Hospital', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}], 'overallOfficials': [{'name': 'Theresa J Gustus, PT, DPT, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newton-Wellesley Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newton-Wellesley Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rehabilitation Services Manager', 'investigatorFullName': 'Theresa J. Gustus', 'investigatorAffiliation': 'Newton-Wellesley Hospital'}}}}