- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00957723
Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study
October 11, 2018 updated by: Stryker Orthopaedics
A Post-market, Non-randomized, Historical Controlled, Multi-center Study of the Outcomes of the Triathlon® Cruciate Retaining (CR) Total Knee System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
419
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85016
- Arizona Institute for Bone and Joint Disorders
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Florida
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Miami, Florida, United States, 33136
- Cedars Medical Center University of Miami
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Georgia
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Columbus, Georgia, United States, 31908
- Hughston Sports Medicine Center
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Iowa
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Cedar Rapids, Iowa, United States, 52401
- Physician's Clinic of Iowa, Mercy Medical Center
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Massachusetts
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Newton, Massachusetts, United States, 02462
- Newton Wellesley Hospital
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New York
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Buffalo, New York, United States, 14203
- Buffalo General Hospital, Department of Orthopaedics Kaleida Health
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Ohio
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Akron, Ohio, United States, 44330
- Crystal Clinic
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Oregon
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Bend, Oregon, United States, 97701
- The Center: Orthopaedic & Neurosurgical Care & Research
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Tennessee
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Knoxville, Tennessee, United States, 37909
- Knoxville Orthopaedic Clinic
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Texas
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Temple, Texas, United States, 76508
- Scott & White Memorial Hospital
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Wisconsin
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Milwaukee, Wisconsin, United States, 53233
- Aurora Advanced Healthcare
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Triathlon® CR Total Knee System
Participants receive the Triathlon® CR Total Knee System
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The purpose is to evaluate the Triathlon® CR Total Knee System.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Active Range of Motion
Time Frame: 2 Years
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2 Years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Knee Society Score (KSS) Over Time
Time Frame: preoperative, 1, 2, and 5 years
|
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.
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preoperative, 1, 2, and 5 years
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Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)
Time Frame: 1, 2, and 5 years
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Knee range of motion is measured by the number of degrees flexion and extension observed.
Active motion is the number of degrees that a participant can extend and flex their knee independently.
Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant.
The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.
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1, 2, and 5 years
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Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score
Time Frame: 1, 2, and 5 years
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Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society.
The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components.
The total widths in millimeters are added for each zone for each of the three prostheses.
The total produces a numerical score for each component.
Failure is defined as a score of 10 or greater, regardless of symptoms.
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1, 2, and 5 years
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Change in SF-36 Health Survey Over Time
Time Frame: preoperative, 1, 2, 3, 4, and 5 years
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The SF-36 Health Survey is a 36 item patient completed questionnaire to measure general health and well-being.
It includes a physical and mental status component score; each ranging from 0-100.
Low values represent a poor health state and high values represent a good health state.
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preoperative, 1, 2, 3, 4, and 5 years
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Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time
Time Frame: preoperative,1, 2, 3, 4 and 5 years
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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.
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preoperative,1, 2, 3, 4 and 5 years
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Change in Lower-Extremity Activity Scale (LEAS) Over Time
Time Frame: preoperative, 1, 2, 3, 4, and 5 years
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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.
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preoperative, 1, 2, 3, 4, and 5 years
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Patellar Subluxation, Dislocation and Fracture Rate
Time Frame: 5 years
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The incidence of patellar subluxation, dislocation or fracture is reported.
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5 years
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Patient Outcome Long Term Follow-up Questionnaire Over Time
Time Frame: 6, 7, 8, 9, and 10 years
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Patient-reported outcome is collected using a long-term follow-up questionnaire at 6, 7, 8, 9, and 10 years postoperative for the subjects who consent to participation in the long-term follow-up study. The questionnaire consists of three yes or no questions:
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6, 7, 8, 9, and 10 years
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Implant Survivorship
Time Frame: 10 years
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Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.
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10 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kirby Hitt, MD, Scott & White Memorial Hospital
- Principal Investigator: Knute Buehler, MD, The Center: Orthopaedic & Neurosurgical Care & Research
- Principal Investigator: Brian Covino, MD, Knoxville Orthopedic Clinic
- Principal Investigator: Joseph Davies, MD, Aurora Advanced Healthcare
- Study Chair: Kenneth Greene, MD, Crystal Clinic
- Principal Investigator: Anthony Hedley, MD, Arizona Institute for Bone and Joint Disorders
- Principal Investigator: Joseph McCarthy, MD, Newton-Wellesley Hospital
- Principal Investigator: Jeffrey Nassif, MD, Physician's Clinic of Iowa, PC
- Principal Investigator: Kenneth Krackow, MD, Buffalo General Hospital, Department of Orthopaedics
- Principal Investigator: Sean Scully, MD, Cedars Medical Center University of Miami
- Principal Investigator: Mathew Phillips, MD, Buffalo General Hospital, Department of Orthopaedics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
September 26, 2017
Study Registration Dates
First Submitted
August 10, 2009
First Submitted That Met QC Criteria
August 11, 2009
First Posted (Estimate)
August 12, 2009
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
October 11, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 56
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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