Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03683992 |
Other study ID # |
201308057 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2013 |
Est. completion date |
December 1, 2023 |
Study information
Verified date |
February 2023 |
Source |
Washington University School of Medicine |
Contact |
rondek salih, MPH |
Phone |
314-747-2495 |
Email |
salihrondek[@]wustl.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.