Louisville, Colorado, United States, October 20, 2026
Synergy Spine Solutions has announced encouraging real-world clinical findings from its PERFORM international study evaluating the Synergy Disc cervical artificial disc replacement device. The results were presented at the North American Spine Society (NASS) 2026 Annual Meeting in San Antonio, Texas, highlighting sustained improvements in neck pain and disability among patients undergoing cervical disc replacement. The ongoing study evaluated 120 patients across five clinical sites in the United Kingdom, the European Union and Australia. Investigators reported that patient-reported outcomes improved following surgery and remained favorable during follow-up. No device-related adverse events, device removals or supplemental fixation procedures were reported during the observed period. Kaplan–Meier analysis estimated 100% device survival through up to four years of follow-up. The findings provide additional real-world evidence on the performance of the Synergy Disc in routine clinical practice. However, the study remains ongoing, and longer-term follow-up will be important for assessing durability and safety. The results add to the clinical evidence for motion-preserving cervical spine surgery, which aims to relieve symptoms while maintaining movement at the treated spinal level.
PERFORM Study Reports Sustained Pain and Disability Improvements
The PERFORM study is an international, multicenter, open-label, pragmatic clinical study that includes prospective and retrospective patient cohorts. It evaluates the Synergy Disc under routine clinical conditions, with safety information collected for all enrolled patients and patient-reported outcomes assessed according to each site’s standard of care. All 120 participants underwent single-level cervical disc replacement, while 30% also received anterior cervical discectomy and fusion (ACDF) during the same operation. The study’s findings showed a substantial reduction in mean Neck Disability Index (NDI) scores, which measure how neck problems affect daily activities. The mean NDI score decreased from 43.4 before surgery to 16.4 at six weeks, then fell to 9.5 at one year and 7.8 at two years. At three years, the mean score remained low at 10.8. Mean neck pain scores also improved, decreasing from 5.8 before surgery to 1.2 at one year and 0.8 at two years. These findings suggest sustained symptom improvement among patients with available follow-up data. Nevertheless, patient-reported outcome data were available for 78% of patients who had reached the one- and two-year visits and 63% of those eligible for three-year follow-up. These follow-up rates should be considered when interpreting the results.
Synergy Disc Shows Favorable Device Survival Findings
The Synergy Disc is designed to replace a damaged cervical intervertebral disc while preserving movement and supporting sagittal alignment, the natural curvature and balance of the spine. Its design incorporates a nickel-free titanium alloy and an ultra-high molecular weight polyethylene articulation, along with a mobile center of rotation and configurations offering zero or six degrees of lordosis. These design features aim to support controlled movement and cervical alignment following surgery. In the PERFORM study, investigators reported no device-related adverse events, explants or supplemental fixation during the observed follow-up period. Kaplan–Meier analysis estimated 100% device survival through up to four years, with participants censored at their last completed follow-up visit. One patient underwent disc replacement at an adjacent spinal level following an acute disc prolapse. The company emphasized that follow-up is continuing to evaluate longer-term clinical outcomes and safety. The absence of reported device-related events in this study is encouraging, but it does not establish that complications cannot occur or that the device will perform identically in every patient population. Real-world studies can complement controlled clinical trials by providing information about device performance across different care settings and patient groups.
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FDA Approval and Further Clinical Evaluation
The Synergy Disc received U.S. Food and Drug Administration (FDA) Premarket Approval in February 2026 for specified single-level cervical disc replacement indications from C3 to C7. The device is commercially available in the United States and has been used internationally for more than a decade, according to the company. At the NASS 2026 meeting, Synergy Spine Solutions also presented two-year results from its U.S. Investigational Device Exemption clinical trial. In that separate study, the Synergy Disc achieved an 87.1% composite clinical success rate, compared with 56.6% for historical ACDF controls. These results should be distinguished from the international PERFORM findings because the studies have different designs and populations. Together, the reports contribute to the evidence base for cervical disc arthroplasty as an alternative to fusion for appropriately selected patients. Continued monitoring will be necessary to clarify long-term durability, clinical outcomes and the patients most likely to benefit. The PERFORM findings support continued evaluation of the Synergy Disc, while additional follow-up and independent research will help establish its performance over time.
Source: Synergy Spine Solutions press release
