Clinical Evidence
Case Studies
Case Study #1
A single-level cervical disc replacement at C5–C6 (Medium implant, 6 mm, 6°). The images below show alignment on upright lateral and range of motion on 24-month flexion-extension.
Outcomes at 24 Months
| Measure | Pre-Op | 24 Month |
|---|---|---|
| Disc Angle | 1.9° | 7° |
| Range of Motion (ROM) | 7.6° | 9.2° |
| Global Lordosis | 9.1° | 21.8° |
| NDI* | 66 | 8 |
| VAS Neck Pain* | 75 | 2 |
| VAS Arm Pain* | 71 | 5 |
Publications
Explore peer-reviewed research and published clinical data on the Synergy Disc.
Clinical Trials
Synergy Spine Solutions is sponsoring two studies in the US under an FDA Investigational Device Exemption (IDE). ALIGN-1L evaluated the Synergy Disc when used at one level, and ALIGN-2L is evaluating the Synergy Disc when used at two consecutive levels in the cervical spine.
ALIGN-1L IDE Study
ALIGN-1L evaluated the safety and effectiveness of the Synergy Disc compared to anterior cervical discectomy and fusion (ACDF) when used at one cervical level. The Synergy Disc group was prospectively enrolled across 20 sites in the US. Data on the fusion group comes from a previously completed randomized controlled trial. The study was completed in June 2025.
Synergy Disc achieved superiority to ACDF on a composite endpoint that required a patient to achieve five clinical success parameters at 2 years after surgery:
- Improvement in function by at least 15 points (0–100 scale) as measured on the Neck Disability Index (NDI).
- Maintenance or improvement in neurological function.
- Absence of additional surgery at the treated level.
- Absence of radiographic failures, defined as any breakage or migration of the study device.
- Absence of device-related serious adverse events.
87.1%
of Synergy Disc patients met all five success criteria at 2 years
56.6%
of ACDF (fusion) patients met the same criteria
Among patients who completed the 24-month visit, additional outcomes favored the Synergy Disc:
- 91.6% of Synergy Disc patients achieved a clinically meaningful improvement (≥15-point improvement) on the Neck Disability Index at 2 years, compared to 74.8% in the fusion group.
- At 2 years, Synergy Disc patients had significantly lower neck pain scores (15.6 on a 0–100 visual analog scale) than the ACDF group (30.2) (p<0.0001).
- Disc angle in the Synergy Disc group increased from 2.6° pre-operatively to 6.5° at 24 months, illustrating an improvement in neck alignment.
- Overall patient satisfaction was higher in the Synergy Disc group at 84.5%, compared to 61.6% in the fusion group.
Enrolled patients are now in long-term follow-up for 3 additional years.
ALIGN-2L IDE Study
ALIGN-2L is a multicenter, prospective trial of the Synergy Disc when used at two consecutive cervical levels, compared to a historical control of 2-level ACDF. The control group uses data from a previously conducted randomized trial comparing a cervical disc to fusion. A total of 200 patients were enrolled and are being followed for 2 years after surgery.
The study is in the follow-up phase and is expected to be completed by the end of 2026. You can learn more about the study here: https://www.clinicaltrials.gov/study/NCT05740176?term=Synergy%20Disc&rank=7
PERFORM Study
The PERFORM study is being conducted in Australia, the UK, and Ireland. This is a real-world study in which patients scheduled for cervical disc replacement using the Synergy Disc are enrolled and followed per their physician’s standard of care. This study will be ongoing for 10 years to collect long-term follow-up on the performance of the Synergy Disc.
Contact Us
If you would like to learn more about our clinical trials, send an inquiry to research@synergyspinesolutions.com.
