Expired Study
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Winfield, Illinois 60190


Purpose:

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.


Study summary:

Primary Hypothesis: The investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone. Secondary Hypotheses: The investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components. The investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA. The 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. The investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the Triathlon Tritanium knee.


Criteria:

Inclusion Criteria: - Symptomatic osteoarthritis of the knee indicating surgical intervention - Scheduled to undergo a total knee arthroplasty - Patients between the ages of 18 and 80, inclusive - Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling Exclusion Criteria: - Significant co-morbidity affecting ability to ambulate - Prior arthroplasty, patellectomy or osteotomy with the affected knee - Active or prior infection of the affected knee - Morbid obesity (BMI > 40) - Medical condition precluding major surgery - Severe osteoporosis - Neuromuscular impairment - Pregnancy - Inability to give informed consent - Inability to return for follow-up visits for a minimum of two years after surgery - Currently participating in any other surgical intervention study - Known allergy to metals - Flexion contracture greater than 15° - Extension lag greater than 10° - Tibial subluxation greater than 10 mm on standing AP radiograph - Lateral or medial collateral ligament instability (> 10° varus/valgus) - Leg length discrepancy greater than 10 mm


NCT ID:

NCT02373761


Primary Contact:

Principal Investigator
Scott Sporer, MD
Central DuPage Hospital

Scott Sporer, MD
Phone: 630-933-6254
Email: scottsporer@gmail.com


Backup Contact:

Email: stefanie.miller@cadencehealth.org
Stefanie Miller, BS
Phone: 630-933-6254


Location Contact:

Winfield, Illinois 60190
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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