Synergy Disc vs ACDF Surgery for Degenerative Disc Disease

Not currently recruiting at 21 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Synergy Disc for individuals with cervical degenerative disc disease (DDD) affecting only one level in the neck, unresponsive to other treatments. The trial aims to determine if the Synergy Disc is as safe and effective as the traditional surgery, anterior cervical discectomy and fusion (ACDF). Participants should experience ongoing symptoms such as neck pain or weakness in the arm or shoulder, with previous non-surgical treatments proving ineffective. This trial suits those with specific neck issues not relieved by other treatments. As an unphased trial, it offers patients the chance to explore a new treatment option that could potentially enhance their quality of life.

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

Research shows that the Synergy Disc, a device used to replace a damaged disc in the neck, is generally well-tolerated by patients with cervical degenerative disc disease (DDD). Studies have found that this disc helps restore neck movement after surgery, which is important for maintaining flexibility and motion.

Evidence from other trials suggests that the Synergy Disc is at least as safe as the traditional surgery called anterior cervical discectomy and fusion (ACDF). This traditional surgery has been established for a long time, so comparing the new disc to it helps clarify its safety.

In previous trials, patients with the Synergy Disc experienced improvements and did not encounter many serious side effects. While all surgeries carry risks, the data so far indicates that the disc is a promising option with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Synergy Disc is unique because it aims to restore natural motion to the cervical spine, unlike the standard anterior cervical discectomy and fusion (ACDF) surgery, which typically limits movement by fusing vertebrae together. This cervical disc prosthesis is designed to maintain the spine's kinematics, which could result in better long-term outcomes for patients. Researchers are excited about the Synergy Disc because it offers a potential solution for preserving mobility while still addressing issues like intractable radiculopathy and myelopathy after discectomy.

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

Research shows that the Synergy Disc is designed to restore neck movement in people with cervical degenerative disc disease (DDD). In this trial, participants will receive either the Synergy Disc or undergo the traditional surgery known as anterior cervical discectomy and fusion (ACDF). Previous patients have shown that the Synergy Disc can be as safe and effective as ACDF. Studies have gathered data from real-world use, showing positive results in terms of safety and effectiveness for people with this condition. The disc replaces damaged parts in the neck, potentially relieving symptoms like pain or nerve problems. While more data is being collected, early findings suggest it could be a promising option for those who haven't had success with other treatments. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

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 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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06383962

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

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

Synergy Disc Clinical Research Clinical research is the process used to collect safety and effectiveness data on new or existing medical devices.

3. 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 ...

4. trialx.com trialx.com/clinical-trials/listings/289460/real-world-data-collection-on-the-synergy-disc/

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.

5. synergyspinesolutions.com synergyspinesolutions.com/synergy-spine-solutions-announces-completion-of-patient-enrollment-in-the-synergy-disc-2-level-ide-clinical-trial/

Synergy Spine Solutions announces completion of patient ... The 2-Level trial will evaluate the safety and effectiveness of the Synergy Disc artificial cervical disc, compared to anterior cervical discectomy and fusion ...

6. 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 ...

7. 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.

8. 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.