Orthopaedics, Muscle & Bone

A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX® Compared ToAutogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfootor Ankle

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.

Primary disease category:

Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH): A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty on Revision Surgery and Quality of Life in Patients with Displaced Femoral Neck F

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.

Primary disease category:

Orthopaedics, Muscle & Bone

A Multi-Center, Randomized, Controlled, Trial of Cerebrospinal Fluid Drainage in Acute Spinal Cord Injury

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.

Primary disease category:

Orthopaedics, Muscle & Bone