Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-01-27 @ 3:51 AM
Study NCT ID:
NCT02373761
Status:
UNKNOWN
Last Update Posted:
2015-02-27
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-26', 'studyFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'pmid': '7744919', 'type': 'RESULT', 'citation': 'Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.'}, {'pmid': '23140091', 'type': 'RESULT', 'citation': 'Pijls BG, Valstar ER, Nouta KA, Plevier JW, Fiocco M, Middeldorp S, Nelissen RG. Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop. 2012 Dec;83(6):614-24. doi: 10.3109/17453674.2012.747052. Epub 2012 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.', 'detailedDescription': 'Primary Hypothesis:\n\nThe investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone.\n\nSecondary Hypotheses:\n\nThe investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components.\n\nThe investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA.\n\nThe investigators expect that inducible displacement exams taken at 2 years post-operative will be able to distinguish between patients identified by RSA measurements as having inadequate fixation.\n\nThe investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the Triathlon Tritanium knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample of patients undergoing total knee replacement with the Triathlon Tritanium knee components at Central DuPage Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic osteoarthritis of the knee indicating surgical intervention\n* Scheduled to undergo a total knee arthroplasty\n* Patients between the ages of 18 and 80, inclusive\n* Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling\n\nExclusion Criteria:\n\n* Significant co-morbidity affecting ability to ambulate\n* Prior arthroplasty, patellectomy or osteotomy with the affected knee\n* Active or prior infection of the affected knee\n* Morbid obesity (BMI \\> 40)\n* Medical condition precluding major surgery\n* Severe osteoporosis\n* Neuromuscular impairment\n* Pregnancy\n* Inability to give informed consent\n* Inability to return for follow-up visits for a minimum of two years after surgery\n* Currently participating in any other surgical intervention study\n* Known allergy to metals\n* Flexion contracture greater than 15°\n* Extension lag greater than 10°\n* Tibial subluxation greater than 10 mm on standing AP radiograph\n* Lateral or medial collateral ligament instability (\\> 10° varus/valgus)\n* Leg length discrepancy greater than 10 mm'}, 'identificationModule': {'nctId': 'NCT02373761', 'briefTitle': 'A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Central DuPage Hospital'}, 'officialTitle': 'A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement', 'orgStudyIdInfo': {'id': '15-034-CDH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stryker Triathlon Tritanium primary knee', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60190', 'city': 'Winfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Central DuPage Hospital', 'geoPoint': {'lat': 41.8617, 'lon': -88.1609}}], 'centralContacts': [{'name': 'Scott Sporer, MD', 'role': 'CONTACT', 'email': 'scottsporer@gmail.com', 'phone': '630-933-6254'}, {'name': 'Stefanie Miller, BS', 'role': 'CONTACT', 'email': 'stefanie.miller@cadencehealth.org', 'phone': '630-933-6254'}], 'overallOfficials': [{'name': 'Scott Sporer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central DuPage Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scott Sporer', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Orthopedic Institute', 'investigatorFullName': 'Scott Sporer', 'investigatorAffiliation': 'Central DuPage Hospital'}}}}