A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement

Status unconfirmed

Conditions studied: Osteoarthritis of the Knee

In brief

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.

Key facts

Study ID

NCT02373761

Run by

Scott Sporer

People needed

27

Starts

2015-02-01

Last updated by the study team

2015-02-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central DuPage Hospital — Winfield, Illinois, United States

Full record on ClinicalTrials.gov

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