Synergy Disc vs. ACDF Surgery for Degenerative Disc Disease

Not currently recruiting at 24 trial locations

Overseen By Jason Tinley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Synergy Spine Solutions

Must not be taking: Steroids, Methotrexate

Disqualifiers: Osteoporosis, Diabetes, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Synergy Disc, a new device designed to help individuals with degenerative disc disease (DDD) in their necks by restoring movement and reducing pain. The trial aims to demonstrate that the Synergy Disc is as safe and effective as the traditional surgery method known as ACDF. Suitable candidates for this trial have experienced severe neck and arm pain due to DDD at two neck levels, have not found relief with other treatments, and have issues like nerve or spinal cord compression. Researchers will monitor participants from before surgery up to two years after to evaluate the device's effectiveness. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future treatment options for DDD.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken drugs that interfere with bone metabolism, like steroids or methotrexate, within two weeks before surgery, or if you need medications that affect implant stability after surgery.

What prior data suggests that the Synergy Disc is safe for treating cervical degenerative disc disease?

Research has shown that the Synergy Disc, a device used in the neck, is under evaluation for safety and effectiveness in treating spinal wear-and-tear. Some studies compare its performance to traditional surgical methods like anterior cervical discectomy and fusion (ACDF).

The Synergy Disc aims to improve spinal movement post-surgery. Although detailed safety information is not yet available, the trial's progression suggests early results were likely positive. Complete safety information will become available once current and future studies conclude. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Synergy Disc because it offers a fresh approach to treating degenerative disc disease in the cervical spine. Unlike the standard treatment, Anterior Cervical Discectomy and Fusion (ACDF), which limits movement by fusing the spine, the Synergy Disc is a prosthetic disc designed to restore natural motion. This innovative device is placed between the vertebrae and helps maintain spinal kinematics, potentially reducing the wear and tear on adjacent discs. By focusing on motion preservation, the Synergy Disc could lead to better long-term outcomes for patients with intractable radiculopathy and myelopathy after discectomy.

What evidence suggests that the Synergy Disc is effective for treating cervical degenerative disc disease?

This trial will compare the Synergy Disc with ACDF surgery for treating degenerative disc disease. Research shows that the Synergy Disc is designed to improve neck movement after surgery on two levels of the neck. It aims to match the safety and effectiveness of the traditional ACDF surgery, commonly used for worn-out neck discs. Studies have found that using a cervical artificial disc like the Synergy Disc can maintain more natural neck movement compared to fusion surgery. This approach might also reduce the likelihood of needing additional surgeries. Early results suggest that the Synergy Disc could be a promising option for individuals with persistent neck pain or nerve issues unresponsive to other treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Josh Butters, ME, MBA

Principal Investigator

Synergy Spine Solutions

Are You a Good Fit for This Trial?

This trial is for adults over 18 with neck pain and cervical degenerative disc disease at two adjacent levels from C3 to C7, who haven't improved with non-surgical treatments. They must have a specific level of disability and pain, documented nerve compression, no severe facet joint issues or certain metabolic disorders, no recent investigational therapy or spinal surgeries (with some exceptions), not be pregnant or planning pregnancy during the study.

Inclusion Criteria

Is willing to comply with the study plan and sign the Patient Informed Consent Form

Neck Disability Index (NDI) score ≥ 30/100

I am not pregnant or nursing and agree not to become pregnant during the study.

Exclusion Criteria

I have had cervical spine surgery before, except for certain types.

I have a hormone or metabolism disorder that affects bone growth.

I have severe joint issues in my spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Evaluation

Patients are evaluated preoperatively to assess baseline conditions and eligibility for surgery

1-2 weeks

1 visit (in-person)

Surgery

Participants undergo surgery for the insertion of the Synergy Disc or conventional ACDF

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored at 6 weeks, and 3, 6, 12, and 24 months after surgery for safety and effectiveness

24 months

5 visits (in-person)

Annual Follow-up

Follow-up continues annually until the last patient reaches 24-month follow-up

Annually

What Are the Treatments Tested in This Trial?

Interventions

• Synergy Disc

Trial Overview The study is testing the Synergy Disc's safety and effectiveness compared to conventional anterior cervical discectomy and fusion (ACDF) surgery in treating cervical degenerative disc disease. Patients will be monitored before surgery and up to 24 months post-surgery to see if this new treatment works as well as the standard one.

How Is the Trial Designed?

Group I: Synergy Disc Experimental Treatment 1 Intervention

The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after anterior discectomy to provide restoration of motion to the functional spinal unit. The Synergy Disc is designed to restore kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a two level discectomy for intractable radiculopathy and/or myelopathy.

Who Is Running the Clinical Trial?

Synergy Spine Solutions

Lead Sponsor

Trials

7

Recruited

780+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04469231?cond=A+Multi-Center%2C+Prospective%2C+Historically-Controlled+Pivotal+Trial+Comparing+The+Safety+And+Effectiveness+Of+The+Synergy+Disc+To+Anterior+Cervical+Discectomy+And+Fusion+In+Patients+With+One-Level+Symptomatic+Cervical+Degenerative+Disc+Disease+%28DDD%29.&draw=2&rank=1

The Synergy Disc To Anterior Cervical Discectomy and ... The objective of this clinical trial is to demonstrate the Synergy Disc is at least as safe and effective as conventional ACDF to treat cervical DDD in subjects ...

2. synergyspinesolutions.com synergyspinesolutions.com/clinical-trial/

Synergy Disc Clinical Research The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following discectomy for intractable radiculopathy and/or myelopathy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06383949

Real World Data Collection on the Synergy Disc The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease. Official Title.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6394883/

Cervical Artificial Disc Replacement Versus Fusion for ... This health technology assessment examined the effectiveness, safety, durability, and cost-effectiveness of cervical artificial disc replacement (C-ADR) versus ...

5. ctv.veeva.com ctv.veeva.com/study/post-market-data-collection-to-evaluate-the-performance-of-the-synergy-disc-r

Post-Market Data Collection to Evaluate the Performance of ... The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7528765/

Patient Selection in Cervical Disc Arthroplasty - PMC Results indicated that 84.3% of surgeons continue to use anterior cervical discectomy and fusion (ACDF) for cervical disc herniation, 47.8% ...

7. thespinemarketgroup.com thespinemarketgroup.com/2025-update-cervical-disc-prostheses-global-status-trends-which-ones-survived-whos-leading-and-what-are-the-real-options-in-2025/

(UPDATED 2025): Cervical Disc Prostheses – Global ... (UPDATED 2025): Cervical Disc Prostheses – Global Status & Trends.Which Ones Survived, Who's Leading, and What Are the Real Options in 2025?