Triathlon Total Stabilizer (TS) Outcomes Study

Stryker

Status

Completed

Conditions

Arthroplasty, Replacement, Knee

Treatments

Device: Triathlon TS Knee System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00958789

Details and patient eligibility

About

This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female 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) > 40.
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.