Triathlon Tritanium Knee Outcomes Study

Stryker Orthopaedics680 enrolled

Overview

The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.

Cases are to be enrolled at five to ten centers. The same center may be included in both arms. Conversely, a center may choose to participate in only a single arm. The enrollment goal is approximately 36 - 72 cases per center for Cohort 1 (cementless) and 15 - 30 cases per center for Cohort 2 (cemented) , and will vary dependent upon the number of participating centers. Although a goal is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the enrollment goal, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) or Ethics Committee (EC) approval. Non-compliance of a study center may result in termination of the center's participation in the study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

680

Conditions

Arthroplasty, Replacement, Knee

Interventions

Triathlon Tritanium KneeDEVICE

Cementless

Triathlon KneeDEVICE

Cemented

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved; study specific Informed Patient Consent Form. 2. Patient is a male or non-pregnant female age 18-75 years at time of study device implantation. 3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 4. Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella. 5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: 1. Patient has a Body Mass Index (BMI) \> 40. 2. Patient has a diagnosis of avascular necrosis or inflammatory arthritis. 3. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. 4. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. 5. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. 6. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). 7. Patient is diagnosed with lumbar radicular pain. 8. Patient has a known sensitivity to device materials. 9. Patient is a prisoner.

Locations (10)

OrthoArizona

Gilbert, Arizona, United States

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Heekin Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System

Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.

Time frame: 2 years

Secondary Outcomes

Implant Survivorship (Baseplate and Patella)

This secondary outcome measure is a statistical estimation on the number of cases at risk at 1-year, 3-years, 5-years and 7-years postoperative in the cementless cohort 1 only, per protocol. The final 10-year results were not done due to early study termination.

Time frame: 10 years

Compare 2011 Knee Society Score (KSS) Scores Between Both Groups

The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Patient Satisfaction and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

Time frame: 2 years

Compare Oxford Knee Score (OKS) Scores Between Both Groups

The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.

Time frame: 2 years

Compare Short Form-12 (SF-12) Scores Between Both Groups

The SF-12 Health Survey is a 12-item patient quality-of-life questionnaire to measure general health and well-being. It is comprised of two distinct scores (physical and mental component score). They are both calculated on a scale ranging from 0 points to 100 points, with low values representing a poor health state and high values representing a good health state.

Data from ClinicalTrials.gov

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