Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT03272178
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.
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Notify Me18 year–75 year
All sexes
Observational
St Louis, Missouri, 63110, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients from Dr Nunley's clinic will get a Depuy implant
patients from Dr Barrack's clinic will get a Triathlon implant
Time frame: 2 years
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 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Time frame: 2 years
EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Washington University School of Medicine
Other
Impact of Component Design and Fixation in Bone Remodeling After Total Knee Arthroplasty
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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