The prospective U.S. IDE study found higher clinical success, reduced pain, and greater patient satisfaction with the Synergy Disc compared to ACDF, while demonstrating the alignment benefits of the device’s differentiated lordotic design.
- Two-year clinical results published in Spine Open demonstrated that the Synergy Disc achieved an 87.1% composite clinical success rate, a strict endpoint requiring patients to meet five individual clinical success criteria, significantly outperforming traditional anterior cervical discectomy and fusion (ACDF) at only a 56.6% composite clinical success rate.
- Patients treated with the Synergy Disc reported roughly half the neck and arm pain of fusion patients, along with significantly higher overall satisfaction.
- The study also demonstrated meaningful restoration of cervical alignment, with disc angle improving from 2.2° preoperatively to 7.5° at 24 months, highlighting the benefits of the device’s unique 6-degree lordotic core.
- Unlike conventional ball-and-socket cervical disc replacement designs that focus primarily on motion preservation, the Synergy Disc combines a 6-degree lordotic core with a design that supports controlled motion, alignment correction and migration resistance, along with nickel-free titanium alloy endplates for patients with nickel sensitivities.
LOUISVILLE, Colo., Sept. 24, 2026 /PRNewswire/ — Synergy Spine Solutions®, a medical device company focused on improving the quality of life for patients undergoing spine surgery, today announced the publication of two-year results from its U.S. Investigational Device Exemption (IDE) 1-Level clinical trial in Spine Open.
The peer-reviewed study found that the Synergy Disc achieved superior composite clinical success compared to anterior cervical discectomy and fusion (ACDF), at 24 months. Patients treated with the Synergy Disc also experienced greater functional improvement, reduced neck and arm pain scores, and higher overall satisfaction.
In addition to the clinical outcomes, researchers observed improvements in segmental and global cervical alignment among Synergy Disc patients. The findings support the device’s differentiated design, which combines motion preservation with a built-in 6-degree lordotic core intended to restore alignment at the treated level.
“Publication of these results gives the spine community a comprehensive view of how the Synergy Disc performed across clinical outcomes, pain, function and alignment,” said Neil Duggal, M.D., Chief Medical Officer of Synergy Spine Solutions and an author of the study. “Cervical disc replacement should do more than maintain movement after surgery. The goal is to preserve motion while restoring the mechanics and alignment of the cervical spine. These findings demonstrate the potential patient benefits of designing a disc around both.”
The prospective, multicenter study included 175 patients treated with the Synergy Disc across 20 U.S. sites and compared their outcomes with 192 propensity-matched historical ACDF control patients. The primary endpoint was composite clinical success at 24 months, which incorporated improvement in Neck Disability Index (NDI) scores, maintenance or improvement in neurological status and the absence of secondary surgery, radiographic failure and device-related serious adverse events.
Among the study’s findings at 24 months:
- 87.1% of Synergy Disc patients achieved composite clinical success, compared with 56.6% of ACDF control patients, meeting the study criteria for superiority (p < 0.0001).
- 91.7% achieved clinically meaningful improvement in Neck Disability Index scores, compared to 75.2% of fusion patients.
- Mean neck pain scores were 15.6 for Synergy Disc patients, compared with 30.2 for fusion patients on a 100-point visual analog scale.
- Worst arm pain scores were 15.0 for Synergy Disc patients, compared with 32.2 in the fusion group. Overall patient satisfaction reached 84.5%, compared with 61.6% for fusion patients.
- Disc angle increased from 2.2 degrees preoperatively to 7.5 degrees at 24 months, demonstrating improved alignment at the treated segment.
“When evaluating new technologies, surgeons want evidence that extends beyond the operating room and demonstrates meaningful patient benefit over time,” said Luis M. Tumialán, MD, a board-certified neurosurgeon and investigator in the Synergy Disc IDE trial. “These results show patients experienced meaningful improvements in pain, function and satisfaction while maintaining motion, which is exactly the type of evidence that helps inform treatment decisions.”
The Synergy Disc received U.S. FDA Premarket Approval in February 2026 for single-level use from C3 to C7. The approval was supported by the IDE study results, including superiority over the fusion control on the primary endpoint of composite clinical success.
Unlike conventional cervical disc replacements designed to maintain motion, the Synergy Disc incorporates a 6-degree lordotic core designed to preserve motion while improving sagittal alignment. The device was designed with migration resistance as an explicit goal, rather than a secondary effect of the implant design. Nickel-free titanium alloy endplates and an ultra-high molecular weight polyethylene core support durability and improved postoperative imaging while expanding access for patients with nickel sensitivities.
“This study’s key strength is that the results connect the Synergy Disc’s design with outcomes that matter to surgeons and patients,” said Robyn Capobianco, Ph.D., Vice President of Clinical Affairs at Synergy Spine Solutions. “This publication adds to a growing body of evidence that cervical disc replacement technology can preserve motion, address alignment, and deliver better clinical outcomes than fusion. That combination is what sets the Synergy Disc apart.”
The Synergy Disc has more than a decade of clinical use outside the United States and has been implanted in thousands of patients across more than 10 countries. It is now commercially available in the United States.
For more information, visit synergyspinesolutions.com.
About Synergy Spine Solutions
Synergy Spine Solutions® is a medical device company focused on improving the quality of life for patients undergoing spine surgery. The company develops motion-preserving technologies designed to treat degenerative disc disease while supporting the spine’s natural curvature. Its flagship product, the FDA-approved Synergy Disc®, features a built-in 6-degree lordotic core designed to not only preserve motion but also improve sagittal alignment.
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SOURCE Synergy Spine Solutions