Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study
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|ClinicalTrials.gov Identifier: NCT00957021|
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : December 5, 2013
Last Update Posted : January 25, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee||Device: Triathlon® PS Total Knee System||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||409 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) Total Knee System|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||January 2014|
Triathlon® PS Total Knee System
Triathlon® PS Total Knee System
Device: Triathlon® PS Total Knee System
Triathlon® PS Total Knee system
- 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.
- Patient Outcome Knee Society Score [ Time Frame: 1,2 and 5 years ]The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
- Patient Outcome SF-36 [ Time Frame: 1,2,3,4 and 5 years ]The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state.
- Patient Outcome WOMAC [ Time Frame: 5 years ]
The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.
Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison.
- Patient Outcome Lower-Extremity Activity Scale [ Time Frame: 1,2,3,4 and 5 years ]The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis.
- Radiographic Outcome [ Time Frame: 1,2 and 5 years ]Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- The subject has inflammatory arthritis.
- The subject is morbidly obese, BMI > 40.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957021
|United States, Georgia|
|Hughston Clinic PA|
|Columbus, Georgia, United States, 31908|
|United States, Indiana|
|Ireland Hip and Knee Surgery|
|Indianapolis, Indiana, United States, 46260|
|United States, Massachusetts|
|New England Baptist Hospital|
|Boston, Massachusetts, United States, 02120|
|Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital|
|Boston, Massachusetts, United States, 02445|
|United States, Minnesota|
|St. Cloud Orthopaedic Associates|
|Sartell, Minnesota, United States, 56377|
|United States, New Hampshire|
|New Hampshire Orthopaedic Surgery, PA|
|Manchester, New Hampshire, United States, 03103|
|United States, New York|
|Harrison, New York, United States, 10528|
|United States, Ohio|
|Wellington Orthopaedics & Sports Medicine|
|Cincinnati, Ohio, United States, 45255|
|Tri County Orthopedic Surgeons, Inc.|
|Massillon, Ohio, United States, 44646|
|United States, Texas|
|Houston, Texas, United States, 77025|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Eric R Benson, MD||New Hampshire Orthopaedic Surgery, PA|
|Principal Investigator:||Daniel Moretta, DO||Tri County Orthopedics Surgeons, Inc.|
|Principal Investigator:||James Bono, MD||New England Baptist Hospital|
|Principal Investigator:||David W Edelstein, MD||Kelsey-Seybold Clinic|
|Principal Investigator:||Philip Ireland, MD||Ireland Hip and Knee Surgery|
|Principal Investigator:||Joseph P Nessler, MD||St. Cloud Orthopaedic Associates|
|Principal Investigator:||Quanjun Cui, MD||University of Virginia|
|Principal Investigator:||Arnold Scheller, MD||Pro-Sports Orthopaedics, Inc./ New England Baptist Hospital|
|Principal Investigator:||Joel Sorger, MD||Wellington Orthopaedics and Sports Medicine|
|Principal Investigator:||Suresh Nayak, MD||Wellington Orthopaedics and Sports Medicine|
|Principal Investigator:||John I Waldrop, MD||Hughston Clinic, PA|
|Principal Investigator:||James McGrory, MD||Hughston Clinic, PA|
|Principal Investigator:||Steven B Zelicof, MD, PhD||Specialty Orthopaedics|
|Responsible Party:||Stryker Orthopaedics|
|Other Study ID Numbers:||
|First Posted:||August 12, 2009 Key Record Dates|
|Results First Posted:||December 5, 2013|
|Last Update Posted:||January 25, 2017|
|Last Verified:||November 2016|