Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

Stryker Orthopaedics419 enrolled

Overview

The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.

The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol). The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as compared to the historical control.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

419

Conditions

Arthroplasty, Replacement, Knee

Interventions

Triathlon® CR Total Knee SystemDEVICE

The purpose is to evaluate the Triathlon® CR Total Knee System.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subject is a male or non-pregnant female between the ages of 21 and 80. 2. The subject requires a primary cemented total knee replacement. 3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). 4. The subject has intact collateral ligaments. 5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form. 6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: 1. Patient has inflammatory arthritis. 2. The subject is morbidly obese, BMI \> 40. 3. The subject has a history of total or unicompartmental reconstruction of the affected joint. 4. Patient has had a high tibial osteotomy or femoral osteotomy. 5. The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device). 6. The patient has a systemic or metabolic disorder leading to progressive bone deterioration. 7. The subject is immunologically suppressed, or receiving chronic steroids (\> 30 days duration). 8. The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis. 9. The subject has had a knee fusion to the affected joint. 10. The subject has an active or suspected latent infection in or about the knee joint. 11. The subject is a prisoner.

Locations (11)

Arizona Institute for Bone and Joint Disorders

Phoenix, Arizona, United States

Cedars Medical Center University of Miami

Miami, Florida, United States

Hughston Sports Medicine Center

Columbus, Georgia, United States

Outcomes

Primary Outcomes

Active Range of Motion

Time frame: 2 Years

Secondary Outcomes

Change in Knee Society Score (KSS) Over Time

The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

Time frame: preoperative, 1, 2, and 5 years

Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)

Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.

Time frame: 1, 2, and 5 years

Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score

Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms.

Time frame: 1, 2, and 5 years

Change in SF-36 Health Survey Over Time

The SF-36 Health Survey is a 36 item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

Data from ClinicalTrials.gov

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