Status:
COMPLETED
Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
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® Crucia...
Detailed Description
The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory deg...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2017
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00957723
Start Date
February 1 2005
End Date
September 26 2017
Last Update
October 12 2018
Active Locations (11)
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1
Arizona Institute for Bone and Joint Disorders
Phoenix, Arizona, United States, 85016
2
Cedars Medical Center University of Miami
Miami, Florida, United States, 33136
3
Hughston Sports Medicine Center
Columbus, Georgia, United States, 31908
4
Physician's Clinic of Iowa, Mercy Medical Center
Cedar Rapids, Iowa, United States, 52401