The Synergy Disc To Anterior Cervical Discectomy and Fusion

Running, not enrolling · Not applicable

Conditions studied: Cervical Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT04469231

Run by

Synergy Spine Solutions

People needed

175

Starts

2020-10-30

Expected to finish

2026-01-01

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 70 years;
• Diagnosis of radiculopathy or myelopathy of the cervical spine, with either radiculopathy symptoms - pain, paresthesia, or paralysis in a specific nerve root distribution C4, C5, C6, or C7, including at least one of the following: arm/shoulder pain (at least 30 mm on 100 mm VAS scale); decreased muscle strength of at least one level on the 0-5 scale described below; abnormal sensation, including hyperesthesia or hypoesthesia; and/or abnormal reflexes; or myelopathy symptoms including positive Romberg evaluation, abnormal heel/toe walk, pathologic hyperreflexia or clonus in lower extremity, positive Babinski, or positive Hoffman's;
• Symptomatic at only one level from C3-C4 to C6-C7;
• Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following:
• Decreased disc height compared to adjacent levels on radiographic film, CT, or MRI
• Degenerative spondylosis on CT or MRI
• Disc herniation on CT or MRI.
• Neck Disability Index (NDI) score ≥ 30/100;
• Unresponsive to non-operative treatment for six weeks, or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment;
• Appropriate for treatment using an anterior surgical approach, including having no more than one previous anterior surgical approach to the cervical spine;
• Ability and willingness to comply with follow-up regimen; and
• Written informed consent given by subject or subject's legally authorized representative.

You may not qualify if…

• Infection at the site of surgery;
• History of, or anticipated treatment for, active systemic infection, including HIV infection or hepatitis C;
• Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy (greater than 6 months prior to scheduled surgical treatment), which includes removal of disc material necessary to perform a nerve root decompression, with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion (greater than 6 months prior to scheduled surgical treatment);
• More than one immobile vertebral level between C1-T1 from any cause, including but not limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior cervical spinal fusions;
• Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous cervical spine injury;
• Axial neck pain in the absence of other symptoms of radiculopathy or myelopathy justifying the need for surgical intervention;
• Radiographic confirmation of severe facet joint disease or degeneration.
• Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) for females or MORES (Male Osteoporosis Risk Estimation Score), will be used to screen patients to determine those patients who require a Hip DXA, a bone mineral density measurement. A SCORE or MORES ≥ 6 requires a DXA. If DXA is required, exclusion will be defined as a DXA bone density measured T score ≤ -2.5 (The World Health Organization definition of osteoporosis). DXA scans within the last 6 months prior to surgical treatment may be used;
• Paget's disease, osteomalacia, or any other metabolic bone disease (excluding osteoporosis which is addressed above);
• Severe diabetes mellitus requiring daily insulin management;
• Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
• Tumor as source of symptoms;
• Symptomatic DDD or significant cervical spondylosis at two or more levels;
• Marked cervical instability on resting lateral or flexion/extension radiographs demonstrated by:
• Translation > 3.5 mm and/or
• 11° angular difference to that of either adjacent level;
• Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;
• Severe myelopathy to the extent that the patient is wheelchair bound;
• Congenital canal stenosis resulting in a canal diameter of < 10 mm, as measured by CT or MRI;
• Kyphotic segmental angulation of greater than 11 degrees at treatment or adjacent levels;
• Arachnoiditis;
• Pregnant (verified in patients of childbearing potential by a negative urine pregnancy test when pre-admission testing is obtained), or interested in becoming pregnant during the duration of the study;
• Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis);
• Congenital bony and/or spinal cord abnormalities that affect spinal stability;
• Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration is likely anticipated within 6 months after the cervical procedure;

Where it is running

• Barrow Brain and Spine — Phoenix, Arizona, United States
• HonorHealth Research Institute/Barrow Brain and Spine — Scottsdale, Arizona, United States
• Todd H. Lanman, M.D. — Beverly Hills, California, United States
• Orthopedic Specialty Institute — Orange, California, United States
• Institute of Neuro Innovation — Santa Monica, California, United States
• Anschutz Medical Center — Aurora, Colorado, United States
• Kennedy White Orthopaedic Center — Sarasota, Florida, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Michigan Orthopedic Surgeons (2) — Southfield, Michigan, United States
• Michigan Orthopedic Surgeons — Southfield, Michigan, United States
• Upstate Medical University — East Syracuse, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Exiamia EquiHealth — Durham, North Carolina, United States
• Summit Spine — Portland, Oregon, United States
• Center for Sports Medicine and Orthopaedic Surgery (CSMO) — Chattanooga, Tennessee, United States
• Central Texas Brain & Spine — Austin, Texas, United States
• Austin Neurosurgeons — Austin, Texas, United States
• Texas Spine Care Center — San Antonio, Texas, United States
• The Disc Replacement Center — West Jordan, Utah, United States
• Atlantic Brain & Spine — Reston, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.