The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery

NCT05740176 | Active Not Recruiting FDA Device

• 1 other identifier: CP 110-0004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Cervical Degenerative Disc Disease

Keywords

degenerative disc disease; cervical; artificial disc replacement; motion preservation; motion preservation disc; cervical TDR

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

• Standardized Neurological Assessment Scales

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

  24 month

• Secondary Surgical Intervention

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

  24 month

• Device Related Adverse Event

  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-36

  pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month

• VAS

  pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month

• Patient Satisfaction

  6 week, 3 month, 6 month, 12 month, 24 month

• BZ Score

  6 week, 3 month, 6 month, 12 month, 24 month

• Odom's Criteria

  6 week, 3 month, 6 month, 12 month, 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 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.

Device: Anterior Cervical Discectomy and Fusion

Interventions

Anterior Cervical Discectomy and Fusion DEVICE

Anterior cervical discectomy is a surgical procedure that was developed to treat damaged cervical discs by relieving pressure on the nerve roots or on the spinal cord by removing the ruptured disc. The operation is performed by reaching the cervical spine through a small incision in the front of the neck. The soft tissues of the neck are then separated allowing for the disc to be removed. Anterior cervical discectomy has proven to be a safe and effective procedure for the treatment of degenerative disc disease. The anterior approach allows direct visualization of the entire interspace and wide decompression of the anterior aspect cervical spinal cord and nerve roots. It may be undertaken in cases of multilevel disease and interbody fusion may be performed if required

Also known as: ACDF

Synergy Disc

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, subjects must meet all of the following criteria:
• Must be at least 18 years of age and be skeletally mature at the time of surgery
• Has a preoperative neck pain score ≥ 8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
• Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 - C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy, or both;
• Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck pain with arm pain, functional deficit and/or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
• Neck Disability Index (NDI) score ≥ 30/100 (raw score of ≥ 15/50);
• Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management; has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s);
• If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;
• Is willing to comply with the study plan and sign the Patient Informed Consent Form

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from participation in this study:
• Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;
• Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:
• Sagittal plane translation \> 3.5 mm, or
• Sagittal plane angulation \> 20°;
• 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);
• Has severe pathology of the facet joints of the involved vertebral bodies;
• Axial neck pain only (no radicular or myelopathy symptoms);
• Has been previously diagnosed with osteomalacia;
• Has presence of spinal metastases;
• Has overt or active bacterial infection, either local or systemic;
• Has insulin-dependent diabetes;
• Has chronic or acute renal failure or prior history of renal disease;
• Known titanium or UHMWPE allergy;
• Is mentally incompetent (if questionable, obtain psychiatric consult);

Sponsors & Collaborators

• Synergy Spine Solutions: lead
• MCRA: collaborator

Study Sites (24)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Todd Lanman, MD

Beverly Hills, California, 90210, United States

Location

DOCS Health Management LLC

Los Angeles, California, 90048, United States

Location

Institute of Neuro Innovation

Santa Monica, California, 91304, United States

Location

Steamboat Orthopaedic and Spine Institute

Steamboat Springs, Colorado, 80487, United States

Location

Brain and Spine Center of South Florida

Delray Beach, Florida, 33445, United States

Location

Kennedy-White Orthopaedic Center

Sarasota, Florida, 34232, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Orthopedics Northeast

Fort Wayne, Indiana, 46825, United States

Location

Precision Spine and Orthopaedic Associates, PA

Overland Park, Kansas, 66211, United States

Location

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

Louisiana Spine Institute

Shreveport, Louisiana, 71101, United States

Location

Michigan Orthopedic Surgeons

Royal Oak, Michigan, 48073, United States

Location

Carolina NeuroSurgery and Spine Associates, PA

Charlotte, North Carolina, 28204, United States

Location

M3 Emerging Medical Research

Durham, North Carolina, 27704, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Summit Spine

Portland, Oregon, 97225, United States

Location

Oregon Spine Care

Tualatin, Oregon, 97062, United States

Location

Austin Neurosurgeons

Austin, Texas, 78746, United States

Location

DFW Center for Spinal Disorders

Fort Worth, Texas, 76132, United States

Location

Texas Back Institute

Plano, Texas, 75093, 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 and Spine

Reston, Virginia, 20190, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Josh Butters, ME, MBA

  Synergy Spine Solutions

  STUDY DIRECTOR

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: multicenter, prospective, historically controlled

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 22, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (24)