This trial is active, not recruiting.

Condition arthroplasty, replacement, knee
Treatment triathlon® cr total knee system
Sponsor Stryker Orthopaedics
Start date February 2005
End date April 2010
Trial size 419 participants
Trial identifier NCT00957723, 56


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Participants receive the Triathlon® CR Total Knee System
triathlon® cr total knee system
The purpose is to evaluate the Triathlon® CR Total Knee System.

Primary Outcomes

Active Range of Motion
time frame: 2 Years
Patellar Subluxation, Dislocation and Fracture Rate
time frame: 10 years

Secondary Outcomes

Knee Society Score (KSS)
time frame: 10 years
SF-36 Health Survey
time frame: 10 years
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
time frame: 10 years
Lower-Extremity Activity Scale (LEAS)
time frame: 10 years
Patient Outcome Long Term Follow-up Questionnaire
time frame: 10 years
Knee Society Total Knee Arthorplasty Roentgenographic Score
time frame: 10 years
Adverse Event Rate
time frame: 10 years

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

Inclusion Criteria: 1. The subject is a male or non-pregnant female between the ages of 21 and 80. 2. The subject requires a primary cemented total knee replacement. 3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). 4. The subject has intact collateral ligaments. 5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form. 6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: 1. Patient has inflammatory arthritis. 2. The subject is morbidly obese, BMI > 40. 3. The subject has a history of total or unicompartmental reconstruction of the affected joint. 4. Patient has had a high tibial osteotomy or femoral osteotomy. 5. 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). 6. The patient has a systemic or metabolic disorder leading to progressive bone deterioration. 7. The subject is immunologically suppressed, or receiving chronic steroids (> 30 days duration). 8. The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis. 9. The subject has had a knee fusion to the affected joint. 10. The subject has an active or suspected latent infection in or about the knee joint. 11. The subject is a prisoner.

Additional Information

Official title A Post-market, Non-randomized, Historical Controlled, Multi-center Study of the Outcomes of the Triathlon® Cruciate Retaining (CR) Total Knee System
Principal investigator Knute Buehler, MD
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 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 Cruciate Retaining (CR) Total Knee System as compared to the historical control.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Stryker Orthopaedics.