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

• Conditions: Osteoarthritis of the Knee

• Registration Number: NCT02373761
• Lead Sponsor: Scott Sporer

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.

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 Timeline

• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-26
• Last Update Submitted: 2015-02-26
• Study First Posted: 2015-02-27
• Last Update Posted: 2015-02-27
• Primary Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.	3 years

Trial Locations

Locations (1)

Central DuPage Hospital; 🇺🇸 Winfield, Illinois, United States