Synergy Disc vs ACDF Surgery for Degenerative Disc Disease

Recruiting at 19 trial locations

Overseen By Nicole Harris

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Synergy Disc Replacement Ltd

Must not be taking: Systemic steroids

Disqualifiers: Infection, Osteoporosis, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 7

175 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using medications that could interfere with bone or soft tissue healing, such as systemic steroids, you may need to stop them. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Synergy Disc for degenerative disc disease?

Research suggests that cervical disc arthroplasty, a treatment similar to the Synergy Disc, may help preserve motion in the spine and potentially reduce the risk of developing new problems in nearby areas compared to traditional fusion surgery. This could make it a more cost-effective option in the long run, despite higher initial costs. ^{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 Synergy Disc. However, these studies suggest that both procedures have known complications, and safety varies based on factors like patient age and surgical setting. ^{6 7 8 9 10}

How does the Synergy Disc treatment differ from other treatments for degenerative disc disease?

The Synergy Disc treatment is unique because it aims to preserve motion in the spine, unlike the traditional ACDF surgery, which fuses the vertebrae and can lead to issues in adjacent segments. This motion-preserving approach may help reduce the risk of developing new problems in nearby areas of the spine. ^{1 2 4 11 12}

What is the purpose of this trial?

A multicenter, prospective, non-randomized, historically controlled study. 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 only one level from C3 to C7 that are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 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.

Eligibility Criteria

This trial is for adults aged 18-70 with cervical degenerative disc disease at one level from C3-C7, who haven't improved after six weeks of non-surgical treatment. Participants should have certain symptoms like arm pain or weakness and be able to follow the study's check-up schedule. People with previous major neck surgeries, multiple affected spinal levels, severe other diseases (like diabetes needing daily insulin), or pregnancy are excluded.

Inclusion Criteria

Written informed consent given by subject or subject's legally authorized representative

My condition hasn't improved after 6 weeks of non-surgical treatment, or my symptoms are getting worse despite treatment.

I am suitable for neck surgery from the front and have had no more than one such surgery before.

Exclusion Criteria

My X-rays show severe wear and tear in my spine joints.

My spinal cord condition has confined me to a wheelchair.

I have been diagnosed with osteoporosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative 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 ACDF procedure

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored at 6 weeks, 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 tests whether the Synergy Disc implant is as safe and effective as traditional surgery (ACDF) for treating single-level cervical degenerative disc disease unresponsive to conservative care. Patients will be monitored over two years with evaluations before surgery and several times postoperatively.

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 restoring kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy.

Who Is Running the Clinical Trial?

Synergy Disc Replacement Ltd

Lead Sponsor

Trials

1

Recruited

180+

Synergy Spine Solutions

Lead Sponsor

Trials

7

Recruited

780+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

MCRA, LLC

Industry Sponsor

Trials

19

Recruited

7,500+

References

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

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. 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]

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

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

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

ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study. [2022]

11. 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]

12. India pubmed.ncbi.nlm.nih.gov

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