This patient population will be recruited from the cohort presenting to Women and Children's Hospital for percutaneous fixation of pediatric supracondylar humerus fractures. Participants will be asked to assent to take part in the study and their parents or guardian will be asked to sign an informed consent. Patients will be randomized to a treatment group that receives one dose of pre-operative antibiotics or one that does not.
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.
Patients that are enrolled in this study will receive an osteochondral allograft from tissue that has been stored in the MOPS instead of the currently standard preservation system (culture media at 4 degrees Celsius). This will be the only difference in the surgical procedure between enrolled patients and non-study patients. Enrolled patients will undergo their grafting procedure as they normally would if they were not enrolled in this study. They will also receive the same care as non-study patients.
At present there are over 1 million people living with Spinal Cord Injury (SCI) in North America alone, with annual costs for the acute treatment and chronic care of these patients totaling four billion dollars USD. The worldwide prevalence of SCI is unknown, with estimates ranging up to 250 million individuals. The incidence of SCI in developed countries has been estimated to be between 10 - 40 cases per million inhabitants.
The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product: 1. Evaluate the performance & accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation. 2. Compare the accuracy of Signature Guides between two user profiles: high volume surgeons & low volume surgeons in a global mix. 3.
September 1, 2012
June 1, 2024
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