An observational study in Arthroplasties, Knee Replacement, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by Washington University School of Medicine · Observational
The purpose of this study is to determine implant design and determine if method of fixation cemented versus cementless results in different bone loss patterns. The investigators also want to determine if clinical outcomes correlate with bone density changes.
Patients who present to the clinical practices of Dr. Ryan Nunley and Dr. Robert Barrack and are suitable candidates for primary total knee arthroplasty(TKA) type assigned either cemented or cementless and Triathlon knee or Depuy by surgeon will be screened for eligibility and invited to participate. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, Dual Energy X-Ray Absorptiometry(DEXA) Bone density monitoring, 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, 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.
A. Patients who qualify for a Primary Total Knee Arthroplasty using Stryker Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant
Exclusion Criteria:
50 Patients who are assigned to Triathlon knee, half cemented/half cementless
Device: Triathlon total knee implant
50 Patients who are assigned to Depuy knee, half cemented/half cementless
Device: Depuy total knee implant
patients from Dr Nunley's clinic will get a Depuy implant
patients from Dr Barrack's clinic will get a Triathlon implant
Change in bone density
Patients will have a DEXA scan to look for change in bone loss at 6 weeks, 1 year, and 2 year to determine bone loss patterns and geometry
Time frame: 2 years
knee society score
Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
Forgotten joint score
Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
Oxford knee score
Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
UCLA Activity score
UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
SF-12
SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
EQ-5D
EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine