Triathlon Total Stabilizer (TS) Outcomes Study

Completed · Not applicable

Conditions studied: Arthroplasty, Replacement, Knee

In brief

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.

Key facts

Study ID

NCT00958789

Run by

Stryker Orthopaedics

People needed

180

Starts

2009-07-01

Expected to finish

2019-03-28

Last updated by the study team

2021-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The CORE Institute — Phoenix, Arizona, United States
• Heekin Institute for Orthopedic Research — Jacksonville, Florida, United States
• Midwest Orthopaedics at Rush — Chicago, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Rothman Institute — Egg Harbor, New Jersey, United States
• Ridgewood Orthopedics — Ridgewood, New Jersey, United States
• Upstate Bone and Joint Center — East Syracuse, New York, United States
• University of North Carolina Orthopedics — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wellington Orthopaedic & Sports Medicine — Cincinnati, Ohio, United States
• The Orthopaedic Center — Tulsa, Oklahoma, United States
• Scott & White Clinic — Temple, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.