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

NCT ID: NCT05740176

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

The proposed investigation is a prospective, non-randomized, multi-center, historically controlled comparison of the Synergy Disc to the control of conventional anterior cervical discectomy and fusion (ACDF) surgery in patients with cervical DDD. A total of 200 patients will be enrolled to the investigational group .The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Synergy Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces that are unresponsive to conservative management.

Conditions

Cervical Degenerative Disc Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Synergy Disc

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.

Group Type: EXPERIMENTAL

Anterior Cervical Discectomy and Fusion

Intervention Type: 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

Interventions

Anterior Cervical Discectomy and Fusion

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

Intervention Type: DEVICE

Other Intervention Names

ACDF

Eligibility Criteria

Inclusion Criteria

In order to be eligible to participate in this study, subjects must meet all of the following criteria:

1. Must be at least 18 years of age and be skeletally mature at the time of surgery

2. Has a preoperative neck pain score ≥ 8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.

3. Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 - C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy, or both;

4. 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.);

5. Neck Disability Index (NDI) score ≥ 30/100 (raw score of ≥ 15/50);

6. 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);

7. If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;

8. Is willing to comply with the study plan and sign the Patient Informed Consent Form

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in this study:

1. Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;

2. Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:

1. Sagittal plane translation > 3.5 mm, or

2. Sagittal plane angulation > 20°;

3. 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);

4. Has severe pathology of the facet joints of the involved vertebral bodies;

5. Axial neck pain only (no radicular or myelopathy symptoms);

6. Has been previously diagnosed with osteomalacia;

7. Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) for females or MORES for males (Male Osteoporosis Risk Estimation Score), will be used to screen patients to determine those patients who require a DXA of the hip, 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;

8. Has presence of spinal metastases;

9. Has overt or active bacterial infection, either local or systemic;

10. Has insulin-dependent diabetes;

11. Has chronic or acute renal failure or prior history of renal disease;

12. Known titanium or UHMWPE allergy;

13. Is mentally incompetent (if questionable, obtain psychiatric consult);

14. Is a prisoner;

15. Is pregnant ;

16. Is currently an alcohol and/or drug abuser or currently undergoing treatment for alcohol and/or drug abuse;

17. Is involved with current or pending litigation regarding a spinal condition;

18. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs;

19. Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);

20. Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs;

21. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MCRA

INDUSTRY

Sponsor Role: collaborator

Synergy Spine Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josh Butters, ME, MBA

Role: STUDY_DIRECTOR

Synergy Spine Solutions

Locations

HonorHealth

Scottsdale, Arizona, United States

Todd Lanman, MD

Beverly Hills, California, United States

DOCS Health Management LLC

Los Angeles, California, United States

Institute of Neuro Innovation

Santa Monica, California, United States

Steamboat Orthopaedic and Spine Institute

Steamboat Springs, Colorado, United States

Brain and Spine Center of South Florida

Delray Beach, Florida, United States

Kennedy-White Orthopaedic Center

Sarasota, Florida, United States

Indiana Spine Group

Carmel, Indiana, United States

Orthopedics Northeast

Fort Wayne, Indiana, United States

Precision Spine and Orthopaedic Associates, PA

Overland Park, Kansas, United States

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, United States

Louisiana Spine Institute

Shreveport, Louisiana, United States

Michigan Orthopedic Surgeons

Royal Oak, Michigan, United States

Carolina NeuroSurgery and Spine Associates, PA

Charlotte, North Carolina, United States

M3 Emerging Medical Research

Durham, North Carolina, United States

Pinehurst Surgical Clinic

Pinehurst, North Carolina, United States

Summit Spine

Portland, Oregon, United States

Oregon Spine Care

Tualatin, Oregon, United States

Austin Neurosurgeons

Austin, Texas, United States

DFW Center for Spinal Disorders

Fort Worth, Texas, United States

Texas Back Institute

Plano, Texas, United States

Texas Spine Care Center

San Antonio, Texas, United States

The Disc Replacement Center

West Jordan, Utah, United States

Atlantic Brain and Spine

Reston, Virginia, United States

Countries

United States

Other Identifiers

CP 110-0004

Identifier Type: -

Identifier Source: org_study_id