Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT06019832
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-17
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Stem and Non-Stem Tibial Component
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Varus Collapse', 'timeFrame': 'up to 5 years post surgery', 'description': 'The investigators will track rate of varus collapse.'}, {'measure': 'Aseptic loosening', 'timeFrame': 'up to 5 years post surgery', 'description': 'The investigators will track rates of aseptic loosening.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obesity', 'Aseptic Loosening', 'Varus Collapse']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare rates of varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA) and will review the degree of influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion.', 'detailedDescription': "The purpose of this study is to identify varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA). In addition, this study will review the degree of influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion.\n\nFemale patients with BMI of 35 kg/m2 and above will be randomized into two groups: the non-stem tibial component (control group) and the stem tibial component (treatment group). Previous studies done in the past in normal weight patients showed that there is little or no advantage in using the stem tibial implants over the non-stem ones. Theoretically, biomechanical studies have suggested that there may be improved fixation and load distribution with the use of stem tibial implants. Thus, it is necessary to see if there is any difference between both implant options among female patients who have the highest incidence of varus collapse. In terms of design, the stem tibial implants are slightly longer than the non-stem ones. They are designed to extends deeper into the tibia to enhance fixation and improve load distribution. The use of either stem tibial implants is usually based on patients' characteristics and surgeons' preference.\n\nFollowing informed consent, standard perioperative patient-reported metrics will be collected (Knee Injury and Osteoarthritis Outcome Score for Joint Replacement \\[KOOS-JR\\], American Knee Society score, and Patient-Reported Outcome Measurement Information System 10 \\[PROMIS-10\\]) before surgery and after surgery (6 weeks, 12 weeks, 1 year, 2 years, 3 years, and 5 years). After surgery, study participants will receive routine surgical care which includes two knee radiographs at 12 weeks and one year. In addition to this, the study participants will be evaluated at 2 years, 3 years, and 5 years postoperative periods where they will complete routine PROMs as listed above and have knee radiographs during each visit."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty\n* 35 kg/m2 and above\n* Only patients from the PI's clinic will be included.\n* Women who are still menstruating and are currently on contraceptives and women who are in menopause.\n\nExclusion Criteria:\n\n* Patients who have some active local or widespread infection (including secondary or inflammatory osteoarthritis)\n* medical conditions that put them at risk of complications or death during and after the study would not be eligible for surgery\n* Patients with previous knee surgery on arthroplasty site will be excluded\n* Pregnant patients and women who are capable of getting pregnant"}, 'identificationModule': {'nctId': 'NCT06019832', 'briefTitle': 'Analysis of Stem and Non-Stem Tibial Component', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '202303366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Stemmed Tibial Implant', 'description': 'This study group will receive a stemmed tibial implant as part of their TKA.', 'interventionNames': ['Procedure: Total Knee Arthroplasty (TKA)', 'Device: Stemmed Tibial Implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Non-Stemmed Tibial implant', 'description': 'This study group will receive a non-stemmed tibial implant as part of their TKA.', 'interventionNames': ['Procedure: Total Knee Arthroplasty (TKA)', 'Device: Non-stemmed tibial implant']}], 'interventions': [{'name': 'Total Knee Arthroplasty (TKA)', 'type': 'PROCEDURE', 'description': 'Both study arms will undergo TKA', 'armGroupLabels': ['Group A: Stemmed Tibial Implant', 'Group B: Non-Stemmed Tibial implant']}, {'name': 'Stemmed Tibial Implant', 'type': 'DEVICE', 'description': 'A stemmed tibial implant', 'armGroupLabels': ['Group A: Stemmed Tibial Implant']}, {'name': 'Non-stemmed tibial implant', 'type': 'DEVICE', 'description': 'non-stemmed tibial implants', 'armGroupLabels': ['Group B: Non-Stemmed Tibial implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacob M. Elkins', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jacob M. Elkins', 'investigatorAffiliation': 'University of Iowa'}}}}