Arthroplasty, Replacement, KneeNCT00957021
Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study
A study testing Triathlon® PS 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® Posterior Stabilized (PS) 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® PS Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2005to Jan 2014
- 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 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.
Who cannot join
- 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.
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 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
New England Baptist Hospital
Boston, Massachusetts, 02120
Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital
Boston, Massachusetts, 02445
University of Virginia
Charlottesville, Virginia, 22903
Wellington Orthopaedics & Sports Medicine
Cincinnati, Ohio, 45255
Hughston Clinic PA
Columbus, Georgia, 31908
Specialty Orthopaedics
Harrison, New York, 10528
Kelsey-Seybold Clinic
Houston, Texas, 77025
Ireland Hip and Knee Surgery
Indianapolis, Indiana, 46260
New Hampshire Orthopaedic Surgery, PA
Manchester, New Hampshire, 03103
Tri County Orthopedic Surgeons, Inc.
Massillon, Ohio, 44646
St. Cloud Orthopaedic Associates
Sartell, Minnesota, 56377
About this study
Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) 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® 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.
Read the 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.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Triathlon® PS Total Knee System
- Keywords
- Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon® PS Total Knee SystemDevice
Triathlon® PS Total Knee system
| Study group | Role | What they receive |
|---|---|---|
| Triathlon® PS Total Knee System | Other | Triathlon® PS Total Knee System Receives: Device: Triathlon® PS Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.
Measured: 2 years
Secondary outcomes (5)
Patient Outcome Knee Society Score
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.
Measured: 1,2 and 5 years
Patient Outcome SF-36
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.
Measured: 1,2,3,4 and 5 years
Patient Outcome WOMAC
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.
Measured: 5 years
Patient Outcome Lower-Extremity Activity Scale
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.
Measured: 1,2,3,4 and 5 years
Radiographic Outcome
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.
Measured: 1,2 and 5 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 startDec 2005
- Primary completionMar 2011
- Study completionJan 2014
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
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric R Benson, MD, Principal investigator, New Hampshire Orthopaedic Surgery, PADaniel Moretta, DO, Principal investigator, Tri County Orthopedics Surgeons, Inc.James Bono, MD, Principal investigator, New England Baptist HospitalDavid W Edelstein, MD, Principal investigator, Kelsey-Seybold ClinicPhilip Ireland, MD, Principal investigator, Ireland Hip and Knee SurgeryJoseph P Nessler, MD, Principal investigator, St. Cloud Orthopaedic AssociatesQuanjun Cui, MD, Principal investigator, University of VirginiaArnold Scheller, MD, Principal investigator, Pro-Sports Orthopaedics, Inc./ New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957021
- Sponsor's protocol ID
- 55
- Status last verified
- Nov 2016
- First submitted
- 10 Aug 2009
- Last updated
- 25 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) Total Knee System
- ClinicalTrials.gov ID
- NCT00957021
- Acronym / sponsor ID
- 55
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Posted 5 Dec 2013
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® 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triathlon® PS Total Knee System | Other | Device: Triathlon® PS Total Knee SystemTriathlon® PS 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 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.
Key exclusion criteria (11 listed)
- 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.
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® PS Total Knee SystemTriathlon® PS Total Knee system | Device | Triathlon® PS Total Knee System |
Primary outcome
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.
5 secondary outcomes
Patient Outcome Knee Society Score
Time frame: 1,2 and 5 years
Patient Outcome SF-36
Time frame: 1,2,3,4 and 5 years
Patient Outcome WOMAC
Time frame: 5 years
Patient Outcome Lower-Extremity Activity Scale
Time frame: 1,2,3,4 and 5 years
Radiographic Outcome
Time frame: 1,2 and 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- 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.
Eric R Benson, MD principal investigator
New Hampshire Orthopaedic Surgery, PA
Daniel Moretta, DO principal investigator
Tri County Orthopedics Surgeons, Inc.
James Bono, MD principal investigator
New England Baptist Hospital
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® PS 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 25 Jan 2017. 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 5 Dec 2013). 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?
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 25 Jan 2017.