Triathlon Tritanium Knee Outcomes Study

Not Applicable

Terminated

• Conditions: Arthroplasty, Replacement, Knee
• Interventions: Device: Triathlon Tritanium Knee; Device: Triathlon Knee

• Registration Number: NCT02155712
• Lead Sponsor: Stryker Orthopaedics

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.

Study Timeline

• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Study Start: 2014-10
• Primary Completion: 2018-04-05
• Results First Submitted: 2019-04-04
• Results First Submitted QC: 2019-06-25
• Results First Posted: 2019-07-16
• Study Completion: 2023-03-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 680

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triathlon Tritanium Knee	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.
Triathlon Knee	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.

Primary Outcome Measures

Name	Time	Method
Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System	2 years	Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.

Secondary Outcome Measures

Name	Time	Method
Compare 2011 Knee Society Score (KSS) Scores Between Both Groups	2 years	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.
Implant Survivorship (Baseplate and Patella)	10 years	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.
Compare Oxford Knee Score (OKS) Scores Between Both Groups	2 years	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.
Compare Short Form-12 (SF-12) Scores Between Both Groups	2 years	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.

Trial Locations

Locations (10)

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Imperial Health; 🇺🇸 Lake Charles, Louisiana, United States

Geisinger Orthopaedic Institute; 🇺🇸 Danville, Pennsylvania, United States

OrthoArizona; 🇺🇸 Gilbert, Arizona, United States

Tucson Orthopaedic Institute; 🇺🇸 Tucson, Arizona, United States

Heekin Clinic; 🇺🇸 Jacksonville, Florida, United States

St. Joseph Mercy Health System; 🇺🇸 Ypsilanti, Michigan, United States

Mission Hospital Research Institute; 🇺🇸 Asheville, North Carolina, United States

Rothman Orthopaedic Institute; 🇺🇸 Egg Harbor Township, New Jersey, United States