Triathlon® Cruciate Retaining (CR) 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® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.

Key facts

Study ID

NCT00957723

Run by

Stryker Orthopaedics

People needed

419

Starts

2005-02-01

Expected to finish

2017-09-26

Last updated by the study team

2018-10-12

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 between the ages of 21 and 80.
• 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…

• Patient has inflammatory arthritis.
• The subject is morbidly obese, BMI > 40.
• The subject has a history of total or unicompartmental reconstruction of the affected joint.
• Patient has had a high tibial osteotomy or femoral osteotomy.
• The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).
• The patient 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, which cannot provide adequate support and/or fixation to the prothesis.
• The subject has had a knee fusion to 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

• Arizona Institute for Bone and Joint Disorders — Phoenix, Arizona, United States
• Cedars Medical Center University of Miami — Miami, Florida, United States
• Hughston Sports Medicine Center — Columbus, Georgia, United States
• Physician's Clinic of Iowa, Mercy Medical Center — Cedar Rapids, Iowa, United States
• Newton Wellesley Hospital — Newton, Massachusetts, United States
• Buffalo General Hospital, Department of Orthopaedics Kaleida Health — Buffalo, New York, United States
• Crystal Clinic — Akron, Ohio, United States
• The Center: Orthopaedic & Neurosurgical Care & Research — Bend, Oregon, United States
• Knoxville Orthopaedic Clinic — Knoxville, Tennessee, United States
• Scott & White Memorial Hospital — Temple, Texas, United States
• Aurora Advanced Healthcare — Milwaukee, Wisconsin, 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.