Biomet, a manufacturer of orthopedic and biotechnology products, has begun enrolling patients in its prospective, randomized, controlled, multicenter SternaLock Blu clinical trial.
The trial will evaluate sternal bone healing after full median sternotomy, by comparing patients whose sternum is closed with conventional wire cerclage with those whose sternum is closed with SternaLock Blu Primary Closure System.
In addition, the trial will provide inputs on post-operative pain and analgesic usage, patient function and quality of life, and complications as well as a comparision of economic costs between the two groups.
The clinical trial is expected to enroll 236 patients from 12 cardiac centers in the US.
Saint Luke’s Hospital cardiothoracic surgeon Keith Allen said Biomet’s commitment to clinical research in the area of sternal closure after heart surgery is important for advancing patient care.
"We are excited that enrollment in the SternaLock Blu study has started and we look forward to adding to the pioneering clinical research that Biomet has already conducted in this space," Allen added.
The company completed clinical trial of SternaLock Primary Closure System in December 2012.