The first patients have been enrolled in a clinical trial evaluating the outcomes of patients who underwent spine surgery with aprevo, Carlsmed's patient-specific spine implant.
The study, known as "Compass" — clinical outcome measures in personalized aprevo spine surgery — is a multicenter post-market prospective observational registry that will collect data on patients treated with aprevo devices and track outcomes over two years.
The study will assess spinal alignment, complications and patient-reported outcome measures for a variety of patients with degenerative spinal conditions.
"The Compass study will generate first-of-its-kind preoperative intervertebral data for surgical planning and personalized aprevo designs along with postoperative metrics for spinal alignment and clinical outcomes," Roland Kent, MD, chief investigator of the study, said in an Oct 11 news release. "After observing excellent initial results with aprevo in my own patients, I am excited to collaborate with colleagues across the country to verify durability of achieved spinal alignment and assess patient satisfaction over the next two years."