Arthroplasty, Replacement, KneeNCT00957723
Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study
A study testing Triathlon® CR Total Knee System in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 11 sites in United States.
Trial 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® Cruciate Retaining (CR) Total Knee System. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Triathlon® CR Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2005to 26 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Crystal Clinic
Akron, Ohio, 44330
The Center: Orthopaedic & Neurosurgical Care & Research
Bend, Oregon, 97701
Buffalo General Hospital, Department of Orthopaedics Kaleida Health
Buffalo, New York, 14203
Physician's Clinic of Iowa, Mercy Medical Center
Cedar Rapids, Iowa, 52401
Hughston Sports Medicine Center
Columbus, Georgia, 31908
Knoxville Orthopaedic Clinic
Knoxville, Tennessee, 37909
Cedars Medical Center University of Miami
Miami, Florida, 33136
Aurora Advanced Healthcare
Milwaukee, Wisconsin, 53233
Newton Wellesley Hospital
Newton, Massachusetts, 02462
Arizona Institute for Bone and Joint Disorders
Phoenix, Arizona, 85016
Scott & White Memorial Hospital
Temple, Texas, 76508
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Triathlon® CR Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon® CR Total Knee SystemDevice
The purpose is to evaluate the Triathlon® CR Total Knee System.
| Study group | Role | What they receive |
|---|---|---|
| Triathlon® CR Total Knee System | Other | Participants receive the Triathlon® CR Total Knee System Receives: Device: Triathlon® CR Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Range of Motion
Measured: 2 Years
Secondary outcomes (9)
Change in Knee Society Score (KSS) Over Time
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.
Measured: preoperative, 1, 2, and 5 years
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)
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.
Measured: 1, 2, and 5 years
Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score
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.
Measured: 1, 2, and 5 years
Change in SF-36 Health Survey Over Time
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.
Measured: preoperative, 1, 2, 3, 4, and 5 years
Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time
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.
Measured: preoperative,1, 2, 3, 4 and 5 years
Change in Lower-Extremity Activity Scale (LEAS) Over Time
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.
Measured: preoperative, 1, 2, 3, 4, and 5 years
Patellar Subluxation, Dislocation and Fracture Rate
The incidence of patellar subluxation, dislocation or fracture is reported.
Measured: 5 years
Patient Outcome Long Term Follow-up Questionnaire Over Time
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:
- Do you have any pain in your knee that has the study knee replacement?
- Are you satisfied with the results of your study total knee replacement?
- Have you had any surgery on your study knee since the time of your last study required visit/contact?
Measured: 6, 7, 8, 9, and 10 years
Implant Survivorship
Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startFeb 2005
- Primary completionApr 2010
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Knute Buehler, MD, Principal investigator, The Center: Orthopaedic & Neurosurgical Care & ResearchBrian Covino, MD, Principal investigator, Knoxville Orthopedic ClinicJoseph Davies, MD, Principal investigator, Aurora Advanced HealthcareKenneth Greene, MD, Study chair, Crystal ClinicAnthony Hedley, MD, Principal investigator, Arizona Institute for Bone and Joint DisordersKirby Hitt, MD, Principal investigator, Scott & White Memorial HospitalJoseph McCarthy, MD, Principal investigator, Newton-Wellesley HospitalJeffrey Nassif, MD, Principal investigator, Physician's Clinic of Iowa, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957723
- Sponsor's protocol ID
- 56
- Status last verified
- Oct 2018
- First submitted
- 10 Aug 2009
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Non-randomized, Historical Controlled, Multi-center Study of the Outcomes of the Triathlon® Cruciate Retaining (CR) Total Knee System
- ClinicalTrials.gov ID
- NCT00957723
- Acronym / sponsor ID
- 56
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Posted 8 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triathlon® CR Total Knee System | Other | Device: Triathlon® CR Total Knee SystemParticipants receive the Triathlon® CR Total Knee System |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triathlon® CR Total Knee SystemThe purpose is to evaluate the Triathlon® CR Total Knee System. | Device | Triathlon® CR Total Knee System |
Primary outcome
Active Range of Motion
Time frame: 2 Years
9 secondary outcomes
Change in Knee Society Score (KSS) Over Time
Time frame: preoperative, 1, 2, and 5 years
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)
Time frame: 1, 2, and 5 years
Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score
Time frame: 1, 2, and 5 years
Change in SF-36 Health Survey Over Time
Time frame: preoperative, 1, 2, 3, 4, and 5 years
Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time
Time frame: preoperative,1, 2, 3, 4 and 5 years
Change in Lower-Extremity Activity Scale (LEAS) Over Time
Time frame: preoperative, 1, 2, 3, 4, and 5 years
Patellar Subluxation, Dislocation and Fracture Rate
Time frame: 5 years
Patient Outcome Long Term Follow-up Questionnaire Over Time
Time frame: 6, 7, 8, 9, and 10 years
Implant Survivorship
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knute Buehler, MD principal investigator
The Center: Orthopaedic & Neurosurgical Care & Research
Brian Covino, MD principal investigator
Knoxville Orthopedic Clinic
Joseph Davies, MD principal investigator
Aurora Advanced Healthcare
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triathlon® CR Total Knee System in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Range of Motion (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.