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Bony Osteosynthesis and Pain After Rigid Sternal Fixation Versus Traditional Wire Closure In High-Risk Sternotomy Patients - Results of a Prospective, Randomized, Multicenter, International Trial
Michael S. Wong, MD1, Sven Lehmann, MD2, Kenton Zehr, MD3, Brian De Guzman, MD4, Lishan Aklog, MD4, H. Edward Garrett, Jr., MD5, Heber MacMahon, MB, BCh6, Brian Hatcher, PhD7, Jaishankar Raman, MD, PhD8.
1University of California Davis Medical Center, Sacramento, CA, USA, 2University of Leipzig Heart Center, Leipzig, Germany, 3Scott & White Clinic, Temple, TX, USA, 4St. Joseph's Hospital and Medical Center, Phoenix, AZ, USA, 5Cardiovascular Surgery Clinic, Memphis, TN, USA, 6University of Chicago Medical Center, Chicago, IL, USA, 7Biomet Microfixation, Jacksonville, FL, USA, 8Rush University Medical Center, Chicago, IL, USA.

PURPOSE: Although median sternotomy is the most frequently performed osteotomy, it is not without morbidity. Pain and disability still occur. We hypothesized rigid plate fixation (RPF) would provide superior bone healing as well as less pain compared to conventional wire closure (CWC). To evaluate 1) sternal osteosynthesis and 2) non-anginal, post-sternotomy chest wall pain in RPF versus CWC patients.
METHODS: In this prospective, randomized, multicenter international trial, 140 patients at high-risk for sternal wound complications were randomized to sternotomy closure via CWC (n=70) or RPF (SternaLock; n=70) following cardiac surgery and median sternotomy. High-risk was defined as the presence of 2 or more of the following: diabetes, chronic obstructive pulmonary disease, obesity, renal failure, chronic steroid use, immunosuppression, redo sternotomy, neurologic dysfunction affecting ambulation, off-midline sternotomy, bilateral internal mammary artery use, cardiopulmonary bypass time >2 hours, and transverse fractures. Sternal osteosynthesis was assessed by two-independent radiologists using a 6-point scale to score 3- and 6-month CT scans. Pain was measured by the visual analog scale as well as narcotic use.
RESULTS: Demographics were well matched for age, BMI, gender, tobacco use and other risk factors. Mean ages of RPF and CWC groups were 66.3±9.8 years and 64.0±8.9 years with obesity (64.3% and 70.0%) and diabetes (69% and 61%) the most common risk factors. Sternal osteosynthesis was significantly greater in RPF versus CWC patients at 3 months (1.7±1.1 versus 0.9±0.8, p=0.003) and 6 months (3.2±1.6 versus 2.2±1.1, p=0.01). At 6 months, 70% of RPF and 24% of CWC patients had osteosynthesis (p=0.003). Pain scores and narcotic usage were lower in rigid plate fixation patients. Significant differences in pain scores were observed at 3 weeks for total pain (p=0.020) and pain with coughing (p=0.0084) or sneezing (p=0.030). Complication rates were similar between groups.
CONCLUSION: High-risk sternotomy patients treated with RPF had superior sternal osteosynthesis and less early postoperative pain compared to CWC.


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