The purpose of the study is to demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis (fusion) or ankle arthrodesis (fusion) surgery with supplemental graft material.
In an elderly population undergoing treatment for displaced, femoral-neck fractures, whether a total or partial hip replacement may have similar or lower rates of revision surgery and higher functional outcome scores at 24 months is unknown. The primary objective is to determine the rates of revision surgery at 2 years in elderly subjects treated for displaced, femoral-neck fractures utilizing a total vs hemi replacement. The secondary objectives are to evaluate quality of life, function, and additional descriptors.
The purpose of this Phase IIB randomized control trial (RCT) is to evaluate the safety and efficacy of cerebrospinal fluid drainage (CSFD) and to provide a preliminary clinical efficacy evaluation of the combination of CSFD and elevation of MAP in patients with acute SCI.