This study is testing the safety and effectiveness of two medical devices, the CEM-Plate Anterior Cervical Plating System and the CEM-Cage Cervical Interbody System. These devices are used together in a surgery called an ACDF (anterior cervical discectomy and fusion) to treat neck pain, spondylosis (a type of arthritis in the spine), and related conditions. You might be able to join if you are between 22 and 79 years old and have specific neck problems, including cervical radiculopathy (pinched nerves in the neck) or myelopathy (spinal cord compression). The study aims to see if these devices lead to successful fusion (when bones grow together) and overall positive outcomes for patients. The study is currently unclear on its recruitment status.

Study design

This is a first-in-human study involving 50 patients. It is a single-arm study, meaning all participants will receive the same treatment.

What's involved

You would undergo a 2-level ACDF surgery and have follow-up visits at 4 weeks, 3, 6, 12, 18, and 24 months. These visits include quality of life assessments and X-rays.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 24 months after the surgery to assess fusion and overall success.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.