Triathlon Tritanium Cone Augments Outcomes Study

Stryker

Status

Active, not recruiting

Conditions

Arthroplasty

Knee

Replacement

Treatments

Device: Triathlon Tritanium Cone Augments

Study type

Interventional

Funder types

Industry

Identifiers

NCT02521103

Details and patient eligibility

About

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.

Full 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.

Enrollment

254 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.