Clinical trial NCT02155712: Triathlon Tritanium Knee Outcomes Study
Official title: Triathlon Tritanium Knee Outcomes Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2014-06-04
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System
timeFrame: 2 years
Secondary outcomes:
measure: Implant Survivorship (Baseplate and Patella)
timeFrame: 10 years
measure: Compare 2011 Knee Society Score (KSS) Scores Between Both Groups
timeFrame: 2 years
measure: Compare Oxford Knee Score (OKS) Scores Between Both Groups
timeFrame: 2 years
measure: Compare Short Form-12 (SF-12) Scores Between Both Groups
timeFrame: 2 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: OrthoArizona
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Jacksonville
country: United States
facility: Heekin Clinic
state: Florida
city: Lake Charles
country: United States
facility: Imperial Health
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Health System
state: Michigan
city: Egg Harbor Township
country: United States
facility: Rothman Orthopaedic Institute
state: New Jersey
city: Asheville
country: United States
facility: Mission Hospital Research Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Danville
country: United States
facility: Geisinger Orthopaedic Institute
state: Pennsylvania
Study officials:
affiliation: Tucson Orthopaedic Institute
name: Edward Petrow, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Rothman Orthopaedic Institute
name: Alvin Ong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heekin Clinic
name: David Heekin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OrthoArizona
name: Kipling Sharpe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mission Hospital Research Institute
name: Marcus Barnett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial Health
name: John Noble, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph Mercy Health System
name: Michael Masini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Samuel Wellman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Hospital of Baltimore
name: Ronald Delanois, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Orthopaedic Institute
name: Thomas Bowen, MD
role: PRINCIPAL_INVESTIGATOR
References: