Triathlon Tritanium Knee Outcomes Study

Stryker

Status: Terminated

Conditions: Arthroplasty, Replacement, Knee

Treatments: Device: Triathlon Knee; Device: Triathlon Tritanium Knee

Study type: Interventional

Funder types: Industry

Identifiers

NCT02155712

74

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 680 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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680 participants in 2 patient groups

Triathlon Tritanium Knee

Active Comparator group

Description:

Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.

Treatment:

Device: Triathlon Tritanium Knee

Triathlon Knee

Active Comparator group

Description:

Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.

Treatment:

Device: Triathlon Knee