Washington University Medical School
St Louis, Missouri, 63110, United States
NCT Number: NCT03683992
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.
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Notify Me18 year–75 year
All sexes
Observational
St Louis, Missouri, 63110, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantable
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.
Time frame: 2 years
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.
Time frame: 2 years
Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.
Time frame: 2 year
Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.
Time frame: 2 years
Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.Subscales are summed together to compute total score.
Time frame: 2 year
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.
Time frame: 2 year
SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.
Time frame: 2 year
EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.
Washington University School of Medicine
Other
Early Outcomes of Cemented Versus Cementless Total Knee Arthroplasty Using the Triathlon Knee
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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