Knee OsteoarthritisNCT03683992
Cemented vs Cementless TKA
An observational study of Knee Osteoarthritis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to compare cemented and cementless versions of the Triathlon total knee arthroplasty/replacement (TKA) in terms of clinical outcomes, perioperative course, and outcome scores including function and patient satisfaction. Patients who present to the clinical practices of Dr. Ryan Nunley, Dr. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Triathlon total knee system
- Type of treatment
- Medical device
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 1 Dec 2023
- How long will I take part?
- 5 Years
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient between the ages of 18-75 getting a total knee surgery.
Who may be able to join
- Patients who qualify for a cementless primary total knee arthroplasty*
- 18 years of age but no more than 75 years of age
- Willing to be randomized
- Willing to sign informed consent
- Willing to return for all follow-up visits
Who cannot join
- Patients with inflammatory arthritis
- BMI equal to 40 or less.
- Patient with an active infection or suspected infection in the operative joint
- The absolute and relative contraindications stated in the FDA cleared labeling for the device
- Patients who have undergone osteotomy
- Patients who have had previous patella fracture or surgery
Show all 10Show fewer
- Patients who have had previous healed tibia or femur fractures
- Patients who have had previous knee or hip replacement surgery on the ipsilateral side
- Patients who require patellar resurfacing
- Patients with major medical/muscular/orthopedic deformities
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Medical School
St Louis, Missouri, 63110
About this study
Official title: Early Outcomes of Cemented Versus Cementless Total Knee Arthroplasty Using the Triathlon Knee
The purpose of this study is to compare cemented and cementless versions of the Triathlon total knee arthroplasty/replacement (TKA) in terms of clinical outcomes, perioperative course, and outcome scores including function and patient satisfaction.
Patients who present to the clinical practices of Dr. Ryan Nunley, Dr. Robert Barrack, or Dr. Denis Nam and are suitable candidates for primary TKA will be screened for eligibility and invited to participate. Once enrolled participants will be randomized (1:1) to either receive a cemented or cementless Triathlon TKA. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 6 months, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing. In addition, a Pain Diary with a pain Visual Analog Scale (VAS) will be assessed once daily at home for 6 weeks after surgery.
Read the detailed description
The purpose of this study is to compare cemented and cementless versions of the Triathlon total knee arthroplasty/replacement (TKA) in terms of clinical outcomes, perioperative course, and outcome scores including function and patient satisfaction.
Patients who present to the clinical practices of Dr. Ryan Nunley, Dr. Robert Barrack, or Dr. Denis Nam and are suitable candidates for primary TKA will be screened for eligibility and invited to participate. Once enrolled participants will be randomized (1:1) to either receive a cemented or cementless Triathlon TKA. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 6 months, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing. In addition, a Pain Diary with a pain Visual Analog Scale (VAS) will be assessed once daily at home for 6 weeks after surgery.
- Conditions
- Knee Osteoarthritis
- Being tested
- Triathlon total knee system
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon total knee systemDevice
Implantable
| Study group | Role | What they receive |
|---|---|---|
| cemented and cementless Triathlon group | cemented group are patients who get randomized to receive cemented knee implant and Patient randomized to receiving cement less knee implant. Receives: Device: Triathlon total knee system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in tourniquet time
Tourniquet time will be recorded for each patient during surgery to see if there is a difference between tourniquet time between patients who are receiving cemented vs cementless.
Measured: 1 year
Secondary outcomes (7)
Difference in functional pain score
Patients will fill out a visual analog scale at 6 weeks, 1 year, 2 year to determine if there is a difference between functional pain score between cemented vs. cementless.
Measured: 2 years
knee society score
Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.
Measured: 2 years
Forgotten joint score
Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.
Measured: 2 year
Oxford knee score
Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.Subscales are summed together to compute total score.
Measured: 2 years
UCLA Activity score
UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Scale from 1 to 10. Higher number represent better outcome. Lower numbers represent worst outcome.
Measured: 2 year
SF-12 questionnaire
SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.
Measured: 2 year
EQ-5D
EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Jan 2013
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683992
- Sponsor's protocol ID
- 201308057
- Status last verified
- Jul 2024
- First submitted
- 19 Sep 2018
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes of Cemented Versus Cementless Total Knee Arthroplasty Using the Triathlon Knee
- ClinicalTrials.gov ID
- NCT03683992
- Acronym / sponsor ID
- 201308057
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 25 Sep 2018 (actual)
- 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.
The purpose of this study is to compare cemented and cementless versions of the Triathlon total knee arthroplasty/replacement (TKA) in terms of clinical outcomes, perioperative course, and outcome scores including function and patient satisfaction.
Patients who present to the clinical practices of Dr. Ryan Nunley, Dr. Robert Barrack, or Dr. Denis Nam and are suitable candidates for primary TKA will be screened for eligibility and invited to participate. Once enrolled participants will be randomized (1:1) to either receive a cemented or cementless Triathlon TKA. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 6 months, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing. In addition, a Pain Diary with a pain Visual Analog Scale (VAS) will be assessed once daily at home for 6 weeks after surgery.
Detailed description
The purpose of this study is to compare cemented and cementless versions of the Triathlon total knee arthroplasty/replacement (TKA) in terms of clinical outcomes, perioperative course, and outcome scores including function and patient satisfaction.
Patients who present to the clinical practices of Dr. Ryan Nunley, Dr. Robert Barrack, or Dr. Denis Nam and are suitable candidates for primary TKA will be screened for eligibility and invited to participate. Once enrolled participants will be randomized (1:1) to either receive a cemented or cementless Triathlon TKA. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 6 months, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing. In addition, a Pain Diary with a pain Visual Analog Scale (VAS) will be assessed once daily at home for 6 weeks after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cemented and cementless Triathlon group | – | Device: Triathlon total knee systemcemented group are patients who get randomized to receive cemented knee implant and Patient randomized to receiving cement less knee implant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient between the ages of 18-75 getting a total knee surgery.
Key inclusion criteria (5 listed)
- Patients who qualify for a cementless primary total knee arthroplasty*
- 18 years of age but no more than 75 years of age
- Willing to be randomized
- Willing to sign informed consent
- Willing to return for all follow-up visits
Key exclusion criteria (10 listed)
- Patients with inflammatory arthritis
- BMI equal to 40 or less.
- Patient with an active infection or suspected infection in the operative joint
- The absolute and relative contraindications stated in the FDA cleared labeling for the device
- Patients who have undergone osteotomy
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 total knee systemImplantable | Device | cemented and cementless Triathlon group |
Primary outcome
Difference in tourniquet time
Time frame: 1 year
Tourniquet time will be recorded for each patient during surgery to see if there is a difference between tourniquet time between patients who are receiving cemented vs cementless.
7 secondary outcomes
Difference in functional pain score
Time frame: 2 years
knee society score
Time frame: 2 years
Forgotten joint score
Time frame: 2 year
Oxford knee score
Time frame: 2 years
UCLA Activity score
Time frame: 2 year
SF-12 questionnaire
Time frame: 2 year
EQ-5D
Time frame: 2 year
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 24 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee Osteoarthritis, run by Washington University School of Medicine 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 5 inclusion and 10 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 24 Jul 2024. 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?
Difference in tourniquet time (time frame: 1 year). 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 24 Jul 2024.