The Synergy Disc To Anterior Cervical Discectomy and Fusion

NCT04469231 | Active Not Recruiting FDA Device

• 1 other identifier: 110-00001
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Cervical Degenerative Disc Disease

Outcome Measures

Primary Outcomes (4)

• NDI

  ≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline

  24 Month

• Neurological Assessment

  Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline

  24 Month

• SSI

  No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level

  24 Month

• Device Related AE

  Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event as adjudicated by the CEC.

  24 Month

Secondary Outcomes (5)

• SF-3

  6 Week, 3, 6, 12, and 24 Month

• VAS

  6 Week, 3, 6, 12, and 24 Month

• Patient Satisfaction

  6 Week, 3, 6, 12, and 24 Month

• BZ Score

  6 Week, 3, 6, 12, and 24 Month

• Odom's Criteria

  6 Week, 3, 6, 12, and 24 Month

Study Arms (1)

Synergy Disc

EXPERIMENTAL

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.

Device: Anterior Cervical Discectomy & Fusion

Interventions

Anterior Cervical Discectomy & Fusion DEVICE

ACDF

Also known as: ACDF

Synergy Disc

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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
• ° angular difference to that of either adjacent level;

Sponsors & Collaborators

• Synergy Spine Solutions: lead
• MCRA: collaborator

Study Sites (20)

Barrow Brain and Spine

Phoenix, Arizona, 85013, United States

Location

HonorHealth Research Institute/Barrow Brain and Spine

Scottsdale, Arizona, 85251, United States

Location

Todd H. Lanman, M.D.

Beverly Hills, California, 90210, United States

Location

Orthopedic Specialty Institute

Orange, California, 92868, United States

Location

Institute of Neuro Innovation

Santa Monica, California, 90404, United States

Location

Anschutz Medical Center

Aurora, Colorado, 80045, United States

Location

Kennedy White Orthopaedic Center

Sarasota, Florida, 34232, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Michigan Orthopedic Surgeons (2)

Southfield, Michigan, 48033, United States

Location

Michigan Orthopedic Surgeons

Southfield, Michigan, 48033, United States

Location

Upstate Medical University

East Syracuse, New York, 13057, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Exiamia EquiHealth

Durham, North Carolina, 27704, United States

Location

Summit Spine

Portland, Oregon, 97225, United States

Location

Center for Sports Medicine and Orthopaedic Surgery (CSMO)

Chattanooga, Tennessee, 37404, United States

Location

Central Texas Brain & Spine

Austin, Texas, 78705, United States

Location

Austin Neurosurgeons

Austin, Texas, 78746, United States

Location

Texas Spine Care Center

San Antonio, Texas, 78231, United States

Location

The Disc Replacement Center

West Jordan, Utah, 84088, United States

Location

Atlantic Brain & Spine

Reston, Virginia, 20190, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, non-randomized, historically controlled study.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 13, 2020
• Study Start: October 30, 2020
• Primary Completion: June 19, 2025
• Study Completion: January 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (20)