Synergy Disc vs. ACDF Surgery for Degenerative Disc Disease

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Synergy Spine Solutions

No Placebo Group

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.

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.

+5 more

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.

+18 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Synergy DiscExperimental Treatment1 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.