Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT04087304
Status:
WITHDRAWN
Last Update Posted:
2022-10-27
First Post:
2019-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was never started, no participants enrolled. Study was closed at Rush', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2019-09-10', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimized Risk Factors', 'timeFrame': 'Optimization time period covers a total time period of 6 months.', 'description': 'A Scoring System Questionnaire with risk factors associated with increased risk of complications in patients undergoing total hip and knee arthroplasty will be collected\n\nRisk factors collected include obesity, drug allergies, presence of osteophytes, soft tissue to patella thickness, flexion contracture, diabetes, chronic opioid use, co-morbidities, prior knee surgeries, etiology of arthritis, smoking status, and reported disability. Each are measured on a scale of -5 to 10, with 10 being the best outcome. All the risk factors are added together and that comprises the total score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee', 'Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'This study is a prospective validation study of a new hip and knee replacement-specific questionnaire that can be used to predict postoperative complications. The purpose of this study is to confirm the validity of a new hip and knee scoring system to be used as a clinical tool to predict potential complication rates in patients undergoing total hip or knee replacement surgery. This scoring system aims to stratify patients into specific risk categories based a standardized calculated score. Patients will be evaluated on health risk factors and severity of disease on radiographic imaging prior to surgery, associated to higher complication rates following surgery. The hopeful anticipated result of this study is a prospective validation of the scoring system with both statistical and clinical significance in predicting postoperative complication rates in patients with moderate to high health risk,\n\nThis stratification system may prove meaningful by allowing these patients, especially those classified as High-Risk, to be incorporated into more appropriate healthcare bundle payment systems that account for their higher financial demands. Furthermore, the stratification may allow for preoperative counseling and a shift towards non-operative management, or surgeon-patient conversations regarding the need to modify a portion of their objective risks prior to surgical intervention. Predictive risk models such as the one presented in the current study will be essential tools as the number of total hip arthroplasty procedures performed each year continue to increase and both the numbers of procedures and associated complications impose a significant cost on the U.S. healthcare system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be male or female of any race.\n2. Patients much be age greater than 18 years old.\n3. Patients undergoing a primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) by participating surgeons at this institution.\n\nExclusion Criteria:\n\n1. Patients with history of native joint infection or active periprosthetic infection according to Musculoskeletal Infection Society (MSIS) Criteria.\n2. Patients requiring removal of hardware during their primary total hip arthroplasty (THA) or total knee arthroplasty (TKA).\n3. Patients requiring use of revision THA or TKA components (stems, augments).\n4. Patients with history of neuromuscular disorder impairing ability to participate in standard postoperative rehabilitation protocol'}, 'identificationModule': {'nctId': 'NCT04087304', 'briefTitle': 'Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Prospective Validation of a Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty', 'orgStudyIdInfo': {'id': '18081101-IRB01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Low Risk Group'}, {'type': 'NO_INTERVENTION', 'label': 'Mild Risk Group'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate Risk Group', 'interventionNames': ['Behavioral: Risk Status Optimization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Risk Group', 'interventionNames': ['Behavioral: Risk Status Optimization']}], 'interventions': [{'name': 'Risk Status Optimization', 'type': 'BEHAVIORAL', 'description': 'Assessment of risk factors putting surgical candidates of total hip and knee arthroplasty at higher risk of complication, and promoting risk factor optimization, thereby decreasing associated risk.', 'armGroupLabels': ['High Risk Group', 'Moderate Risk Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brett Levine, MD', 'investigatorAffiliation': 'Rush University Medical Center'}}}}