Status:
COMPLETED
Triathlon Total Stabilizer (TS) Outcomes Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 op...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00958789
Start Date
July 1 2009
End Date
March 28 2019
Last Update
October 22 2021
Active Locations (12)
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1
The CORE Institute
Phoenix, Arizona, United States, 85023
2
Heekin Institute for Orthopedic Research
Jacksonville, Florida, United States, 32204
3
Midwest Orthopaedics at Rush
Chicago, Illinois, United States, 60612
4
Tufts Medical Center
Boston, Massachusetts, United States, 02111