A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years. [3 years]
Secondary Outcome Measures
- Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires. [3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Symptomatic osteoarthritis of the knee indicating surgical intervention
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Scheduled to undergo a total knee arthroplasty
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Patients between the ages of 18 and 80, inclusive
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Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling
Exclusion Criteria:
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Significant co-morbidity affecting ability to ambulate
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Prior arthroplasty, patellectomy or osteotomy with the affected knee
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Active or prior infection of the affected knee
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Morbid obesity (BMI > 40)
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Medical condition precluding major surgery
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Severe osteoporosis
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Neuromuscular impairment
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Pregnancy
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Inability to give informed consent
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Inability to return for follow-up visits for a minimum of two years after surgery
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Currently participating in any other surgical intervention study
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Known allergy to metals
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Flexion contracture greater than 15°
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Extension lag greater than 10°
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Tibial subluxation greater than 10 mm on standing AP radiograph
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Lateral or medial collateral ligament instability (> 10° varus/valgus)
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Leg length discrepancy greater than 10 mm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central DuPage Hospital | Winfield | Illinois | United States | 60190 |
Sponsors and Collaborators
- Scott Sporer
- Stryker Orthopaedics
Investigators
- Principal Investigator: Scott Sporer, MD, Central DuPage Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-034-CDH