Synergy Disc Outperforms ACDF at Two Years, ALIGN-1L Data Shows

Synergy Spine Solutions presented two-year primary endpoint results from its U.S. IDE 1-Level clinical trial of the Synergy Disc (ALIGN-1L trial) at this year’s Society for Minimally Invasive Spine Surgery (SMISS) annual forum.

Presented by investigator Amir Vokshoor, MD, FAANS, the study found Synergy Disc achieved higher composite clinical success than anterior cervical discectomy and fusion (ACDF) at 24 months (87.1% vs. 56.6%). Synergy Disc patients also reported greater functional improvement, reduced neck and arm pain, and higher satisfaction, along with improved segmental and global cervical alignment.

The device combines motion preservation with a built-in 6-degree lordotic core designed to restore alignment at the treated level. The Synergy Disc received FDA premarket approval in February 2026 for single-level use from C3 to C7, supported by IDE data showing superiority over fusion on the primary composite clinical success endpoint.

Unlike conventional cervical disc replacements, its 6-degree lordotic core is designed to preserve motion while improving sagittal alignment, with migration resistance incorporated into the design.

Nickel-free titanium alloy endplates and an ultra-high molecular weight polyethylene core are intended to support durability, imaging, and use in patients with nickel sensitivities. Published estimates indicate a nickel allergy affects up to 17% of women and 3% of men.

“The clinical results presented at the SMISS Annual Forum give us a clear picture of what this technology means for patients, from pain relief and excellent clinical outcomes to restored motion and improved spinal alignment,” said Josh Butters, CEO of Synergy Spine Solutions. “The data reflects years of surgeon-led innovation and clinical validation, showing that the Synergy Disc successfully addresses both motion preservation and sagittal alignment in a single, reliable device.”

More about the ALIGN-1L study results

The Synergy Disc group had a 92% NDI responder rate at 24 months, compared with 75% for fusion patients. Mean neck and worst arm pain scores were also lower with Synergy Disc (15.6 vs. 30.2 and 15.0 vs. 32.2, respectively).

Patient satisfaction reached 92.3%, compared with 61.6% for fusion. Global C2–C7 lordosis increased 27%, while patients with preoperative segmental kyphosis achieved an average 8.6-degree correction, from −3.5 degrees to +5.1 degrees.

“While traditional cervical disc replacements preserve motion, many available devices are designed primarily to maintain preoperative alignment rather than actively restore segmental lordosis or optimize sagittal balance,” said presenting author Amir Vokshoor, MD, FAANS, of the Neurosurgery & Spine Group in Santa Monica, California. “The two-year results from the ALIGN-1L trial demonstrate that the Synergy Disc’s unique lordotic core improves spinal alignment, especially in patients presenting with baseline kyphotic segments, while delivering superior pain and disability relief compared to fusion. These findings demonstrate the value of addressing alignment as part of motion-preserving cervical disc replacement.”