View clinical trials related to Orthopedic Procedures.
Filter by:The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional 3-week blood donation period before surgery) in patients who are not anemic and who will be undergoing orthopedic, heart and blood vessel, or breast reduction surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production. Normovolemic hemodilution (NVHD, withdrawal of a patient's blood immediately before surgery, immediate replacement of blood with an equal volume of fluid, and return of the withdrawn blood after completion of surgery; a procedure which reduces the loss of blood during surgery) will also be performed.
Twelve subjects will be sought for this study. Six subjects will receive the DYNESYS system and six subjects will receive a posterior lumbar interbody fusion (PLIF) with the Silhouette device. All subjects will already be participating in the DYNESYS multi-center study (under IRB #4884) and will have been randomized to either group. Five tantalum beads will be inserted into each vertebra associated with the DYNESYS or fusion surgery. Subjects will be followed in conjunction with the multi-center follow-up schedule and will have RSA exams at the following time points after surgery: 3, 6, 12, 18, and 24 months. Standing neutral, flexion, extension, and lateral bending films will be collected at each time point and the amount of motion in each direction of the "marked" vertebrae will be measured. The time points have been selected based on their clinical relevance for comparison against the standard of care, which is the fusion procedure. Depending on the initial tension of the annular fibers, it is possible the DYNESYS will exhibit more motion with time. The time points are important to track the potential changes.