Arthroplasty, Knee, Replacement
Conditions
Brief summary
The purpose of this study was to evaluate the success rate of the Triathlon Tritanium Cone Augment with the Triathlon TS Total Knee System at 2 years postoperative, defined as absence of revision of the Femoral Cone Augment or Tibial Cone augment for aseptic loosening.
Detailed description
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative. The total enrollment goal for the study is 145 cases have received the Triathlon TS Total Knee System with a Triathlon Tritanium Cone Augment. Additionally, between 40-50 cases (within the study population) will receive the Triathlon TS Total Knee System with a Triathlon Tritanium Central Femoral Cone Augment.
Interventions
DEVICETriathlon Tritanium Cone Augments
The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in revision TKA.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form. * Patient is a male or non-pregnant female, skeletally mature and age 18 years or older at time of study device implantation. * Patient is a candidate for revision of all femoral and tibial components of a total knee replacement. * Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
* Patient has a Body Mass Index (BMI) \> 45. * Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. * Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. * Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration. * Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * Patient has a failed unicondylar knee prosthesis. * Patient has a known sensitivity to device materials. * Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cases With Revision of the Femoral Cone Augment or Tibial Cone Augment for Aseptic Loosening. | 2 year | The primary efficacy parameter is the revision/removal of femoral cone augment or tibial cone augment for aseptic loosening at 2 years postoperative. Success at 2 years is defined as no incidence of revision/removal of femoral or tibial cone augment for aseptic loosening within 2 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Location and Severity of End-of-stem Pain. | 2 year | End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain. Pain for both the shin and thigh are identified using the following categories: * no pain * pain with extreme activity only * pain with moderate activity * pain with normal activity * pain at rest |
| Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape. | Intraoperative | The AORI is a bone defect classification which consists of four Types: Type I: Metaphyseal bone is intact, with minor bone defects not compromising component stability. Type IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed. Type IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed. Type III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlvin Ong, MD
Rothman Institute
PRINCIPAL_INVESTIGATORMichael Masini, MD
Michigan Heart, St. Joseph Health System
PRINCIPAL_INVESTIGATORYogesh Mittal, MD
The Orthopaedic Center
PRINCIPAL_INVESTIGATORDavid Markel, MD
The CORE Institute
PRINCIPAL_INVESTIGATORCraig Della Valle, MD
Rush University Medical Center
PRINCIPAL_INVESTIGATORAjay Aggarwal, MD
Missouri Orthopaedic Institute
PRINCIPAL_INVESTIGATORLouis S Stryker, MD
The University of Texas Medical Branch (UTMB)
PRINCIPAL_INVESTIGATOREdward J Stolarski, MD
Gulfcoast Research Institute
PRINCIPAL_INVESTIGATORJoshua Drumm, DO
Providence Medical Research Center
PRINCIPAL_INVESTIGATORGerald E Alexander, MD
Orlando Health
PRINCIPAL_INVESTIGATORKevin Denehy, MD
Bluegrass Orthopaedics
Participant flow
Recruitment details
There were 254 participants / 259 cases that were enrolled in the study (this includes 5 bilateral participants).
Pre-assignment details
Of the 254 participants (259 cases) enrolled, 64 participants (65 cases) were censored from the analysis, per the Sponsor's internal guidelines. Therefore,190 participants (194 cases) who did receive the study device and met protocol criteria, were followed. Those applicable data are reflected in this record.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 167 Participants |
| Sex: Female, Male Female | 122 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 194 | 11 / 190 |
| other Total, other adverse events | 43 / 194 | 0 / 0 |
| serious Total, serious adverse events | 29 / 194 | 11 / 190 |
Outcome results
None listed