Triathlon Tritanium Knee Outcomes Study

NCT ID: NCT02155712

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2023-03-11

Brief Summary

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.

Detailed 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.

Conditions

Arthroplasty, Replacement, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triathlon Tritanium Knee

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.

Group Type: ACTIVE_COMPARATOR

Triathlon Tritanium Knee

Intervention Type: DEVICE

Cementless

Triathlon Knee

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.

Group Type: ACTIVE_COMPARATOR

Triathlon Knee

Intervention Type: DEVICE

Cemented

Interventions

Triathlon Tritanium Knee

Cementless

Intervention Type: DEVICE

Triathlon Knee

Cemented

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Petrow, DO

Role: PRINCIPAL_INVESTIGATOR

Tucson Orthopaedic Institute

Alvin Ong, MD

Role: PRINCIPAL_INVESTIGATOR

Rothman Orthopaedic Institute

David Heekin, MD

Role: PRINCIPAL_INVESTIGATOR

Heekin Clinic

Kipling Sharpe, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoArizona

Marcus Barnett, MD

Role: PRINCIPAL_INVESTIGATOR

Mission Hospital Research Institute

John Noble, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial Health

Michael Masini, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph Mercy Health System

Samuel Wellman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Ronald Delanois, MD

Role: PRINCIPAL_INVESTIGATOR

Sinai Hospital of Baltimore

Thomas Bowen, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Orthopaedic Institute

Locations

OrthoArizona

Gilbert, Arizona, United States

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Heekin Clinic

Jacksonville, Florida, United States

Imperial Health

Lake Charles, Louisiana, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

St. Joseph Mercy Health System

Ypsilanti, Michigan, United States

Rothman Orthopaedic Institute

Egg Harbor, New Jersey, United States

Mission Hospital Research Institute

Asheville, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Geisinger Orthopaedic Institute

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

74

Identifier Type: -

Identifier Source: org_study_id