The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
Median sternotomy patients will be randomized to either wire or rigid fixation groups. A scheduled evaluation period will record clinical parameters. Enrollment has ended with one hundred forty (140) patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
patients will have their sternum closed using wire (stainless steel surgical wire).
St. Joseph's Heart and Lung Institute
Phoenix, Arizona, United States
University of California Davis Medical Center
Sacramento, California, United States
University of Chicago
Chicago, Illinois, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
CT Scan Evaluation of Sternal Bone Healing
Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)
Time frame: 3 and 6 Months
Activity Based Total Visual Analog Pain Score
Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an "Activity Based Total Visual Analog Pain Score", (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated.
Time frame: 6 months
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Scott & White Memorial Hospital
Temple, Texas, United States
Leipzig Heart Center
Leipzig, Germany