A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) Total Knee System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stryker Orthopaedics
- Enrollment
- 409
- Locations
- 11
- Primary Endpoint
- Range of Motion
Study Overview
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® 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.
Detailed Description
The Triathlon® Posteriorly Stabilized (PS) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol).
The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon® PS Total Knee System.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •The subject has inflammatory arthritis.
- •The subject is morbidly obese, BMI >
- •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.
Arms & Interventions
Triathlon® PS Total Knee System
Triathlon® PS Total Knee System
Intervention: Triathlon® PS Total Knee System (Device)
Outcomes
Primary Outcomes
Range of Motion
Time Frame: 2 years
The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.
Secondary Outcomes
- Patient Outcome Knee Society Score(1,2 and 5 years)
- Patient Outcome SF-36(1,2,3,4 and 5 years)
- Patient Outcome Lower-Extremity Activity Scale(1,2,3,4 and 5 years)
- Patient Outcome WOMAC(5 years)
- Radiographic Outcome(1,2 and 5 years)