The Synergy Disc clinical study reports sustained improvements in neck pain and disability two years after cervical disc replacement, according to results the company presented at the North American Spine Society 2026 annual meeting in San Antonio. Synergy Spine Solutions says its PERFORM international real-world study of 120 patients at five sites in the UK, the European Union and Australia found that mean Neck Disability Index scores fell from 43.4 before surgery to 7.8 at two years, and mean neck-pain scores fell from 5.8 to 0.8. The study is ongoing, open-label and has no control group, so the findings do not show the device is superior to alternatives.
Synergy Disc clinical study: key takeaways
- PERFORM is an ongoing, international, open-label, pragmatic real-world study of 120 patients at five sites, per Synergy Spine Solutions’ announcement of 20 October 2026.
- Mean Neck Disability Index fell from 43.4 before surgery to 7.8 at two years; mean neck pain fell from 5.8 to 0.8.
- No device-related adverse events, explants or supplemental fixation were reported during follow-up.
- Patient-reported data were available for 78% of patients at one and two years but only 63% at three years.
- There is no control group, and 30% of patients also had fusion at an adjacent level in the same surgery.
What the Synergy Disc clinical study (PERFORM) is
According to the company, PERFORM is an ongoing, international, multicenter, open-label, pragmatic study with prospective and retrospective cohorts that evaluates the Synergy Disc in routine practice. Safety data were collected for all patients, while patient-reported outcomes followed each site’s standard of care. All 120 patients had single-level cervical disc replacement, and 30% also had anterior cervical discectomy and fusion, or ACDF, in the same surgery. The Synergy Disc is an artificial cervical disc with a nickel-free titanium alloy and an ultra-high molecular weight polyethylene articulation, a mobile centre of rotation and options of 0 or 6 degrees of lordosis. More on the company is on the Synergy Spine Solutions website.
Synergy Disc clinical study results over time
| Time point | Mean Neck Disability Index | Mean neck pain score |
|---|---|---|
| Before surgery | 43.4 | 5.8 |
| Six weeks | 16.4 | Not reported |
| One year | 9.5 | 1.2 |
| Two years | 7.8 | 0.8 |
| Three years | 10.8 | Not reported |
By our calculation, the mean Neck Disability Index fell by 35.6 points between surgery and two years, and mean neck pain by 5.0 points on the scale used. The three-year disability score of 10.8 is higher than at two years, a small rise that the announcement does not discuss and that comes from fewer patients with data.
Synergy Disc clinical study: safety and device survival
The company reports no device-related adverse events, explants or supplemental fixation during follow-up. A Kaplan-Meier analysis estimated 100% device survival through up to four years, with patients censored at their last completed visit, which means the estimate reflects only the time each patient was observed. One patient had a disc replacement at an adjacent level after an acute disc prolapse. The announcement does not describe arm pain outcomes or give a three-year neck-pain figure.
How to read the Synergy Disc clinical study
This section is our analysis. A real-world study such as PERFORM follows patients treated in everyday practice, so it can show how a device performs outside the tightly controlled conditions of a randomised trial. It cannot, however, show that the device caused the improvement, because many patients improve after surgery whatever implant is used and there is no comparison group. Missing patient-reported data, which reached 37% at three years, can also bias results if patients who did worse were less likely to respond. Real-world evidence complements controlled trials and does not replace them.
Regulatory status and the US trial
The company says the Synergy Disc received FDA premarket approval in February 2026 for single-level use from C3 to C7 and is now commercially available in the United States, after more than a decade of use outside it. It also reported two-year results from its U.S. IDE one-level trial: among patients with evaluable data, the composite clinical success rate was 87.1% versus 56.6% for historical ACDF controls, which the company says met non-inferiority and superiority criteria. Because the comparison uses historical controls and not a concurrent randomised group, we treat it as the company’s claim, and it is separate from PERFORM. General regulator information is on the FDA medical devices pages.
The NASS meeting
The results were presented at the North American Spine Society annual meeting. The company also sponsored a non-CME debate on the role of arthroplasty in spine surgery, in which Roland S. Kent, M.D., presented the case for disc replacement. Chief Medical Officer and founder Neil Duggal said that reducing pain and disability is central to helping patients regain function after cervical disc replacement.
What the Synergy Disc clinical study does not disclose
- Arm pain outcomes and three-year neck pain.
- The profile of patients who did not provide follow-up data.
- Comparisons with fusion or other discs in a randomised design.
- Long-term safety beyond the follow-up reported.
Risks and caveats on the Synergy Disc clinical study
- The study is ongoing and open-label, with no concurrent control group.
- Patient-reported data cover 63% of patients at three years.
- Results should not be read as proof the device is superior to every alternative.
- This is news reporting, not medical advice.
In our assessment, the Synergy Disc clinical study gives encouraging two-year real-world numbers for a device now on the U.S. market, and the open questions are how much of the gain comes from the disc itself and how well results hold at three years and beyond. See also FDA Approves Rejoni's Juveena Hydrogel System for Preventing Intrauterine Adhesions. More in our medical device coverage.
What to watch next on the Synergy Disc clinical study
- Further follow-up from PERFORM, including complete three-year data.
- Publication of the U.S. IDE results in a peer-reviewed journal.
- Comparative studies against other cervical discs and fusion.
Frequently asked questions
What did PERFORM find?
Mean Neck Disability Index fell from 43.4 to 7.8 and mean neck pain from 5.8 to 0.8 at two years, per the company.
Is this proof the Synergy Disc is better than other options?
No. The study is open-label with no control group and cannot show superiority.
Is the Synergy Disc approved in the United States?
The company says it received FDA premarket approval in February 2026 for single-level use from C3 to C7.
How we reported this: we relied on Synergy Spine Solutions’ announcement of 20 October 2026 and public regulator pages. Our calculations and general background are labelled. Last updated: 20 October 2026. This article is news reporting and not medical advice.