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



Status:Not yet recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:February 2015
Contact:Scott Sporer, MD
Email:scottsporer@gmail.com
Phone:630-933-6254

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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.

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.

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
We found this trial at
1
site
Winfield, Illinois 60190
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mi
from
Winfield, IL
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