Synergy Two Level Cervical Disc replacement now enrolling

The Synergy Disc Clinical Trial

Summit Spine and Dr Sales are proud to offer our patients enrollment in the Synergy Disc trial. We completed the one level study in 2023. We have been enrolling eligible patients into the two level study since the Fall of 2023.

The Synergy Disc clinical trial is a multicenter, non-randomized, historically controlled study designed to show that the Synergy Disc is at least as safe and effective as an Anterior Cervical Discectomy and Fusion (ACDF) procedure to treat a degenerated cervical disc at one level. All patients qualifying for participation in this clinical trial will receive the Synergy Disc.

Cervical degenerative disc disease (DDD) is a condition characterized by degenerated and/or diseased discs leading to nerve root and/or spinal cord compression in the cervical spine. The treatment continuum spans from conservative treatments and therapies to surgical procedures. While less prevalent than low back pain, cervical DDD is equally debilitating and requires careful clinical management to ensure patients return to a normal quality of life.

The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after cervical discectomy to provide restoration of motion and alignment to the functional spinal unit. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy.

If enrolled, the cost of the surgery and care is covered by the Synergy. There are 8 visits in the first two years of the study, all of them in the office. After the first two years, there may be additional annual follow up visits.

You will be asked to complete several patient questionnaires and answer questions about your general health and any medications you may be taking. The rest of the visits will be routine for this type of surgery.

There are no additional costs to you for participation in the study. Your insurance will pay for the routine care and Synergy Spine Solutions^® Ltd (the trial Sponsor) will pay for the rest of it. If you qualify to be in the study, you will be compensated for your time and travel.

Combining Cervical Alignment & Balance with Natural Motion

• Maintains natural motion
• Restores sagittal alignment with unique lordotic core
• Achieves balance in single or multi-level procedures
• Reduces focal deformities

The design innovations in the Synergy Disc provides a physiologic, dynamic center of rotation (COR) in flexion and extension, as well as lateral bending and axial rotation.

The Synergy Disc design offers clinical benefits over existing total disc replacement devices with additional features that include the following.

• Unique, lordotic core geometry 
• Low-profile disc heights
• Multiple, anatomic footprints
• Semi-constrained design with safety stops
• Stability zone that provides balance
• MRI imaging friendly
• Time-tested orthopedic materials

The simple surgical steps with a secure fixation method provides predictable, reproducible and reliable results.

Author

J. Rafe Sales MD