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

Launched by SCOTT SPORER · Feb 26, 2015

Keywords

ClinConnect 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 ...

Gender

ALL

Eligibility 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