Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study

Completed · Not applicable

Conditions studied: Arthroplasty, Replacement, Knee

In brief

The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio® PS implant.

Key facts

Study ID

NCT00957021

Run by

Stryker Orthopaedics

People needed

409

Starts

2005-12-01

Expected to finish

2014-01-01

Last updated by the study team

2017-01-25

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment.
• The subject requires a primary cemented total knee replacement.
• The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
• The subject has intact collateral ligaments.
• The subject has signed the IRB approved, study specific Informed Patient Consent Form.
• The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if…

• The subject has inflammatory arthritis.
• The subject is morbidly obese, BMI > 40.
• The subject has a history of total or unicompartmental reconstruction of the affected joint.
• The subject has had a high tibial osteotomy or femoral osteotomy.
• The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
• The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
• The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
• The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
• The subject has had a knee fusion at the affected joint.
• The subject has an active or suspected latent infection in or about the knee joint.
• The subject is a prisoner.

Where it is running

• Hughston Clinic PA — Columbus, Georgia, United States
• Ireland Hip and Knee Surgery — Indianapolis, Indiana, United States
• New England Baptist Hospital — Boston, Massachusetts, United States
• Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital — Boston, Massachusetts, United States
• St. Cloud Orthopaedic Associates — Sartell, Minnesota, United States
• New Hampshire Orthopaedic Surgery, PA — Manchester, New Hampshire, United States
• Specialty Orthopaedics — Harrison, New York, United States
• Wellington Orthopaedics & Sports Medicine — Cincinnati, Ohio, United States
• Tri County Orthopedic Surgeons, Inc. — Massillon, Ohio, United States
• Kelsey-Seybold Clinic — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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