Triathlon Tritanium Knee Outcomes Study

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Triathlon Tritanium Knee Outcomes Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02155712
• Other study ID #: 74
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: March 11, 2023

Study information

• Verified date: October 2023
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 680
• Est. completion date: March 11, 2023
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Triathlon Tritanium Knee
Cementless
• Triathlon Knee
Cemented

Locations

Country	Name	City	State
United States	Mission Hospital Research Institute	Asheville	North Carolina
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Geisinger Orthopaedic Institute	Danville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Rothman Orthopaedic Institute	Egg Harbor Township	New Jersey
United States	OrthoArizona	Gilbert	Arizona
United States	Heekin Clinic	Jacksonville	Florida
United States	Imperial Health	Lake Charles	Louisiana
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	St. Joseph Mercy Health System	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	10 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years