View clinical trials related to Sternal Closure.
Filter by:Post-operative recovery after cardiac surgery is influenced by early sternal bone stability. Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless steel wires. Augmenting sternal closure with techniques to enhance early bone stability should accelerate functional recovery from cardiac surgery thereby reducing post-operative pain, decreasing the need for narcotics, improving breathing and chest wall mechanics, stimulating early mobility and expediting hospital discharge. This study is a randomized, single-centre, double-blind clinical study comparing the effects of Montage bone putty plus conventional wire closure vs conventional wire closure only on the post-operative recovery of cardiac surgery patients with full medial sternotomy.
Design: Investigator Initiated Prospective Randomised Trial Study Centre's: Melbourne Private Hospital Royal Melbourne Hospital Study Hypothesis: Use of the SternaLock 360 will reduce the incidence of sternal motion > 2mm by absolute difference of 40% at 6 weeks of surgery compared to stainless steel wiring. Use of the SternaLock 360 will improve bone healing and quality of recovery after surgery compared to stainless steel wiring Study Objective: To determine if the SternaLock 360 system reduces sternal instability, increases bone healing, and improves quality of recovery compared to stainless steel wiring of the sternum, after cardiac surgery involving median sternotomy Inclusion Criteria: Age ≥ 18 year old Elective cardiac surgery Primary cardiac surgical procedure No evidence of infection at time of surgery Sufficient English language to complete the Postoperative Quality of Recovery Survey Exclusion Criteria: Previous sternotomy (redo) Clinical sternal deformity Home locality preventing follow-up (e.g. remote regional, interstate or overseas patient) Number of Planned Subjects: 50
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG) in patients undergoing surgery for coronary artery disease. Given the increasing risk profile of contemporary cardiac surgery patients, sternal complications are subject to increase concomitantly. Despite advances in many areas of cardiac surgical procedures, innovation in sternal closure technique has been lacking and postoperative complications remain. In this study, the investigators aim to assess the effectiveness of using a novel osteoconductive biologic bone cement (KryptoniteTM, Doctors Research Group Inc.) as an adjunct to conventional sternal closure in post CABG patients having median sternotomy. The outcomes of interest for this study will include: pain, discomfort, lung function, wound healing and analgesic use. The investigators assume that the use of KryptoniteTM will decrease postoperative pain leading to improvement in postoperative lung function. This may also lead to improvement in patient recovery and decrease in postoperative complications. The investigators will undertake a single-blinded randomized, controlled study consisting of patients undergoing elective coronary artery bypass grafting (CABG) randomly assigned to either Group A (usual closure with stainless steel wires) or Group B (usual closure with stainless steel wires plus application of bone cement). Each group will consist of 64 patients in a total of 128 patients. Lung function data using a spirometer will be collected preoperatively and 3rd and 5th postoperative days as well as in outpatient clinic. Pain data will be collected on the 1st to 5th postoperative days.