New artificial disc aims to replace fusion for neck disc disease

NCT ID NCT05740176

Disease control Sponsor: Synergy Spine Solutions Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study tests a new artificial disc called the Synergy Disc for people with two-level cervical degenerative disc disease (DDD) who haven't improved with non-surgical care. The disc is designed to replace damaged discs in the neck while preserving motion, unlike standard fusion surgery which locks the bones together. Researchers will compare the safety and effectiveness of the Synergy Disc to historical data from fusion patients, tracking outcomes like pain, function, and need for additional surgery over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Synergy Disc (artificial cervical disc)
What this could lead to: If successful, this could offer a motion-preserving alternative to spinal fusion for people with two-level cervical disc disease, potentially reducing the need for repeat surgeries.
What could go wrong: This is a non-randomized, historically controlled trial with 200 participants, so results may be less reliable than a randomized study. The device could fail, cause complications, or not prove superior to fusion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cervical disk degenerative disorder intervertebral disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical degenerative disc disease

Contacts and locations

Locations

Atlantic Brain and Spine

Reston, Virginia, 20190, United States
Austin Neurosurgeons

Austin, Texas, 78746, United States
Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States
Brain and Spine Center of South Florida

Delray Beach, Florida, 33445, United States
Carolina NeuroSurgery and Spine Associates, PA

Charlotte, North Carolina, 28204, United States
DFW Center for Spinal Disorders

Fort Worth, Texas, 76132, United States
DOCS Health Management LLC

Los Angeles, California, 90048, United States
HonorHealth

Scottsdale, Arizona, 85258, United States
Indiana Spine Group

Carmel, Indiana, 46032, United States
Institute of Neuro Innovation

Santa Monica, California, 91304, United States
Kennedy-White Orthopaedic Center

Sarasota, Florida, 34232, United States
Louisiana Spine Institute

Shreveport, Louisiana, 71101, United States
M3 Emerging Medical Research

Durham, North Carolina, 27704, United States
Michigan Orthopedic Surgeons

Royal Oak, Michigan, 48073, United States
Oregon Spine Care

Tualatin, Oregon, 97062, United States
Orthopedics Northeast

Fort Wayne, Indiana, 46825, United States
Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States
Precision Spine and Orthopaedic Associates, PA

Overland Park, Kansas, 66211, United States
Steamboat Orthopaedic and Spine Institute

Steamboat Springs, Colorado, 80487, United States
Summit Spine

Portland, Oregon, 97225, United States
Texas Spine Care Center

San Antonio, Texas, 78231, United States
The Disc Replacement Center

West Jordan, Utah, 84088, United States
Todd Lanman, MD

Beverly Hills, California, 90210, United States

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