Synergy Disc vs. ACDF Surgery for Degenerative Disc Disease

Recruiting at 23 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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

A multicenter, prospective, non-randomized, historically controlled study. To demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.

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 data supports the effectiveness of the treatment Synergy Disc for Degenerative Disc Disease?

Research comparing cervical disc arthroplasty (a type of surgery that preserves motion) with anterior cervical discectomy and fusion (ACDF) shows that disc arthroplasty can be effective for treating degenerative disc disease, suggesting that similar treatments like the Synergy Disc may also be beneficial. ^{1 2 3 4 5}

Is the Synergy Disc generally safe for humans?

The available research primarily compares the safety of anterior cervical discectomy and fusion (ACDF) and cervical total disc replacement (cTDR), but does not specifically address the safety of the Synergy Disc. However, these studies suggest that both ACDF and cTDR have known complications, and safety varies based on factors like patient age and surgical setting. ^{6 7 8 9 10}

How is the Synergy Disc treatment different from ACDF surgery for degenerative disc disease?

The Synergy Disc treatment is unique because it aims to preserve motion in the spine, unlike ACDF surgery, which fuses the vertebrae and can lead to loss of mobility and issues in adjacent segments. This motion-preserving approach may help reduce complications associated with traditional fusion surgeries. ^{1 3 11 12 13}

Research Team

Jane M Jacob, PhD

Principal Investigator

Synergy Spine Solutions

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Disc prosthesis versus fusion with cage in single level cervical degenerative spine disease - A retrospective case-control patient reported outcome study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparing outcomes of anterior cervical discectomy and fusion in workman's versus non-workman's compensation population. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Comparison of early clinical effects between Activ C cervical disc replacement and anterior cervical discectomy and fusion for single-level cervical spondylosis]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Posterior foraminotomy versus anterior decompression and fusion in patients with cervical degenerative disc disease with radiculopathy: up to 5 years of outcome from the national Swedish Spine Register. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of the adverse events of anterior cervical disc replacement versus anterior cervical discectomy and fusion: A protocol for a systematic review and meta-analysis of prospective randomized controlled trials. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion: Comparison of 30-Day Population Comorbidities and Perioperative Complications Using 6 Years of American College of Surgeons National Surgical Quality Improvement Program Participant Use File Data. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Cervical arthroplasty versus anterior cervical fusion for symptomatic adjacent segment disease after anterior cervical fusion surgery: Review of treatment in 41 patients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Outpatient anterior cervical discectomy and fusion in the ambulatory surgery center setting: safety assessment for the Medicare population. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of Outpatient Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta-Analysis. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Hybrid implants in anterior cervical decompressive surgery for degenerative disease. [2022]

12. England pubmed.ncbi.nlm.nih.gov

A comparison of zero-profile anchored spacer (ROI-C) and plate fixation in 2-level noncontiguous anterior cervical discectomy and fusion- a retrospective study. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Research protocol: Cervical Arthroplasty Cost Effectiveness Study (CACES): economic evaluation of anterior cervical discectomy with arthroplasty (ACDA) versus anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical degenerative disc disease - a randomized controlled trial. [2022]