An interventional study of Instrument in Osteoarthritis of the Knee, 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 2018-06-27.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery:
Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 25 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Other: Instrument
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Other: Instrument
Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.
Also known as: Vanguard® Knee System, Signature™ Custom Guides
Patient dissatisfaction following primary total knee replacement.
Time frame: Preoperatively, intraoperatively, and at four to six weeks, three months, six months, and one year postoperatively.
Postoperative recovery time following primary total knee replacement.
Time frame: Immediate postoperative period (prior to discharge) and at four to six weeks, three months, six months, and one year postoperatively.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine