Clinical Studies Overview
Spine Fusion Overview
Spine fusion is a widely performed surgical procedure to treat degenerative disc disease, spondylolisthesis and other debilitating spine conditions. The vast majority of fusion procedures are in the neck (cervical spine) or low back (lumbar spine) and can be due to normal deterioration as we age. In an interbody fusion procedure, the surgeon uses small incisions to access the spine and remove the diseased disc and any surrounding bone that is pressing against the nerve roots. The spine is then distracted to restore the normal height of the spine segment, and the surgeon places a bone graft into the prepared disc space. The role of the bone graft is to promote bridging of new bone between the vertebra, permanently joining the bones together, eliminating painful motion at this segment and supporting the normal height of the spine.
The goal of a successful procedure is to fuse the painful motion segment together, making the bone graft a critical component in a successful outcome.
Find out more about spine fusion here.
Amplex™ Clinical Trials
The interbody fusion technique is widely used in lumbar spine surgeries due to the benefit of a less invasive approach and preservation of many of the surrounding soft tissue structures. The lumbar region presents a very challenging environment for any bone graft to achieve a successful fusion outcome. For this reason, BioSET has selected the lumbar spine to initiate human clinical trials of Amplex and critically determine the potential of Amplex as equivalent to the "gold standard" of iliac crest bone autograft.
These clinical trials are rigorous, prospective, randomized, controlled, multi-center studies that are currently underway in the U.S. and Canada, each with the regulatory approval of the country's medical device authority.1,2,3 The results of these pilot studies will form the foundation of a pivotal clinical study (Phase III) which may ultimately lead to regulatory authorization and commercial availability to surgeons and their patients.
The Amplex clinical trials are suited for select patients suffering from single level degenerative disc disease (DDD) or Grade I Spondylolisthesis (Spondy) of the L2 – S1 segments of the spine.
Find out more about participating in the Amplex studies at www.prefixstudy.com.
- FDA: Investigational Device Exemption approval IDE# G070139
- Health Canada: Investigational Testing Authorization ITA# 135574
- Note that the pilot studies were conducted under the trade name “Prefix”.