Osteoarthritis, KneeNCT01367925
Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study
An observational study of Osteoarthritis, Knee, run by Spokane Joint Replacement Center at 1 site in United States.
Trial summary
This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Stryker Triathlon® CS Tibial Insert and Stryker Triathlon® PS Tibial Insert
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing total knee arthroplasty
Who may be able to join
- Adults ages 20-80 years old
- Body mass index <40
- Undergoing primary total knee arthroplasty for osteoarthritis of the knee
Who cannot join
- Inflammatory arthritis
- Revisions
- Other criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Spokane Joint Replacement Center
Spokane, Washington, 99218
About this study
Official title: A Prospective, Randomized, Comparison of Total Knee Arthroplasty With the Triathlon® CS Tibial Insert vs. the Triathlon® PS Tibial Insert.
This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Stryker Triathlon® CS Tibial Insert, Stryker Triathlon® PS Tibial Insert
- Keywords
- Osteoarthritis, Total Knee Replacement, TKA, Knee, PS, CS
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker Triathlon® CS Tibial InsertDevice
Stryker Triathlon® PS Tibial InsertDevice
| Study group | Role | What they receive |
|---|---|---|
| Cruciate Substituting Tibial Insert | Not described Receives: Device: Stryker Triathlon® CS Tibial Insert | |
| Posterior Stabilized Tibial Insert | Not described Receives: Device: Stryker Triathlon® PS Tibial Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes, Knee Society Score
Clinical outcomes to include overall success, failure rate, revison rate, clinical scores (Knee Society Score), range of motion, pain, stability, radiographic success
Measured: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startDec 2007
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spokane Joint Replacement Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David F. Scott, MD, Spokane Joint Replacement Center
- Investigators
- David F Scott, MD, Principal investigator, Spokane Joint Replacement Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367925
- Sponsor's protocol ID
- SJRC-CS/PS
- Status last verified
- Dec 2017
- First submitted
- 22 May 2011
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparison of Total Knee Arthroplasty With the Triathlon® CS Tibial Insert vs. the Triathlon® PS Tibial Insert.
- ClinicalTrials.gov ID
- NCT01367925
- Acronym / sponsor ID
- SJRC-CS/PS
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Total Knee Replacement, TKA, Knee, PS, CS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Spokane Joint Replacement CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cruciate Substituting Tibial Insert | – | Device: Stryker Triathlon® CS Tibial Insert |
| Posterior Stabilized Tibial Insert | – | Device: Stryker Triathlon® PS Tibial Insert |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing total knee arthroplasty
Key inclusion criteria (3 listed)
- Adults ages 20-80 years old
- Body mass index <40
- Undergoing primary total knee arthroplasty for osteoarthritis of the knee
Key exclusion criteria (3 listed)
- Inflammatory arthritis
- Revisions
- Other criteria may apply
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 |
|---|---|---|
| Stryker Triathlon® CS Tibial Insert | Device | Cruciate Substituting Tibial Insert |
| Stryker Triathlon® PS Tibial Insert | Device | Posterior Stabilized Tibial Insert |
Primary outcome
Clinical outcomes, Knee Society Score
Time frame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Clinical outcomes to include overall success, failure rate, revison rate, clinical scores (Knee Society Score), range of motion, pain, stability, radiographic success
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Related trials for Osteoarthritis, Knee
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
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.
David F Scott, MD principal investigator
Spokane Joint Replacement Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Spokane Joint Replacement Center at 1 site 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 3 inclusion and 3 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 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical outcomes, Knee Society Score (time frame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative). 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 13 Dec 2017.