Clinical trial NCT02521103: Triathlon Tritanium Cone Augments Outcomes Study
Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthroplasty
Replacement
Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening
timeFrame: 2 year
Secondary outcomes:
measure: Presence of end-of-stem pain in relation to the Triathlon Tritanium Cone Augments location.
timeFrame: 2 year
measure: Severity of end-of-stem pain.
timeFrame: 2 year
measure: Anderson Orthopaedic Research Institute (AORI) classification and Femoral Cone Augment size.
timeFrame: intraoperative
measure: Anderson Orthopaedic Research Institute (AORI) classification and Tibial Symmetric Cone Augment size.
timeFrame: intraoperative
measure: Anderson Orthopaedic Research Institute (AORI) classification and Tibial Asymmetric Cone Augment size.
timeFrame: intraoperative
Other outcomes:
Locations:
city: Zephyrhills
country: United States
facility: Florida Medical Clinic
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Orthopaedics
state: Kentucky
city: Novi
country: United States
facility: The CORE Institute
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart, St. Joseph Health System
state: Michigan
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Tulsa
country: United States
facility: The Orthopaedic Center
state: Oklahoma
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
Study officials:
References: