- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05740176
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
January 15, 2024 updated by: Synergy Spine Solutions
A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing the Safety and Effectiveness of the Synergy Disc to Anterior Cervical Discectomy and Fusion in Patients With Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jane M Jacob, PhD
- Phone Number: 512-289-5370
- Email: janejacob@synergyspinesolutions.com
Study Contact Backup
- Name: Lisa Beck
- Phone Number: 202-552-5800
- Email: lbeck@mcra.com
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90210
- Recruiting
- Todd Lanman, MD
-
Contact:
- Nicole Phillips
- Email: research@spine.md
-
Los Angeles, California, United States, 90048
- Not yet recruiting
- DOCS Health Management LLC
-
Contact:
- Babak Khandehroo
- Email: research@docshealth.com
-
Santa Monica, California, United States, 91304
- Recruiting
- Institute of Neuro Innovation
-
Contact:
- Jack Petros
- Email: research@inifoundation.org
-
-
Colorado
-
Steamboat Springs, Colorado, United States, 80487
- Recruiting
- Steamboat Orthopaedic and Spine Institute
-
Contact:
- Abigail Wiedel
- Email: lmanzanres@steamboatortho.com
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Not yet recruiting
- Yale University Neurosurgery
-
Contact:
- Hugh Medvecky
- Email: hugh.medvecky@yale.edu
-
-
Florida
-
Sarasota, Florida, United States, 34232
- Recruiting
- Kennedy-White Orthopaedic Center
-
Contact:
- Sara Wood
- Email: swood@kwoc.net
-
-
Indiana
-
Carmel, Indiana, United States, 46032
- Recruiting
- Indiana Spine Group
-
Contact:
- Sheetal Vinayek
- Email: svinayek@indianaspinegroup.com
-
-
Kansas
-
Overland Park, Kansas, United States, 66211
- Not yet recruiting
- Precision Spine and Orthopaedic Associates, PA
-
Contact:
- Robin Keswani
- Email: robin@researchtex.com
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Not yet recruiting
- Bone and Joint Clinic of Baton Rouge
-
Contact:
- Heather Bowman
- Email: hbowman@louisianaspine.org
-
Shreveport, Louisiana, United States, 71101
- Not yet recruiting
- Louisiana Spine Institute
-
Contact:
- Heather Bowman
- Email: hbowman@louisianaspine.org
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- Recruiting
- Michigan Orthopedic Surgeons
-
Contact:
- Courtney Watterworth
- Email: courtney.watterworth@corewellhealth.org
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Not yet recruiting
- Carolina NeuroSurgery and Spine Associates, PA
-
Contact:
- Ginger Barr
- Email: ginger.barr@csna.com
-
Durham, North Carolina, United States, 27704
- Recruiting
- M3 Emerging Medical Research
-
Contact:
- Shandelle Parker
- Email: sparker@wakeresearch.com
-
-
Oregon
-
Portland, Oregon, United States, 97225
- Recruiting
- Summit Spine
-
Contact:
- Sean Brown
- Email: pacsean@gmail.com
-
Tualatin, Oregon, United States, 97062
- Recruiting
- Oregon Spine Care
-
Contact:
- Kelsey Gretzinger
- Email: kelsey@oregonspinecare.org
-
-
Texas
-
Austin, Texas, United States, 78746
- Recruiting
- Austin Neurosurgeons
-
Contact:
- Robin Keswani
- Email: robin@researchtex.com
-
Fort Worth, Texas, United States, 76132
- Recruiting
- DFW Center for Spinal Disorders
-
Contact:
- Robin Keswani
- Email: robin@researchtex.com
-
San Antonio, Texas, United States, 78231
- Recruiting
- Texas Spine Care Center
-
Contact:
- Robin Keswani
- Email: robin@researchtex.com
-
-
Utah
-
West Jordan, Utah, United States, 84088
- Recruiting
- The Disc Replacement Center
-
Contact:
- Veronica Scarth
- Email: veronicalscarth@centura.org
-
-
Virginia
-
Reston, Virginia, United States, 20190
- Recruiting
- Atlantic Brain and Spine
-
Contact:
- Meghan Martin
- Email: meghan@brainspinesurgery.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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
Exclusion Criteria:
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;
- 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;
- 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);
- Is a prisoner;
- Is pregnant ;
- Is currently an alcohol and/or drug abuser or currently undergoing treatment for alcohol and/or drug abuse;
- Is involved with current or pending litigation regarding a spinal condition;
- 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;
- 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);
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NDI
Time Frame: 24 month
|
≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline
|
24 month
|
Standardized Neurological Assessment Scales
Time Frame: 24 month
|
Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
|
24 month
|
Secondary Surgical Intervention
Time Frame: 24 month
|
No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index levels
|
24 month
|
Device Related Adverse Event
Time Frame: 24 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF-36
Time Frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
|
Health Survey (SF-36) at baseline and at each follow-up time-point
|
pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
|
VAS
Time Frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
|
Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant.
Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point.
Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point.
Please note, this assessment will include a "Worst" to pool together the left or right arm/shoulder scores with the higher baseline score.
VAS Hoarseness on a 100mm scale.
|
pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
|
Patient Satisfaction
Time Frame: 6 week, 3 month, 6 month, 12 month, 24 month
|
Patient Satisfaction Questionnaire
|
6 week, 3 month, 6 month, 12 month, 24 month
|
BZ Score
Time Frame: 6 week, 3 month, 6 month, 12 month, 24 month
|
Bazaz Dysphagia Score at 24 months compared to baseline
|
6 week, 3 month, 6 month, 12 month, 24 month
|
Odom's Criteria
Time Frame: 6 week, 3 month, 6 month, 12 month, 24 month
|
Results at 24 months for the investigational Synergy Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.
|
6 week, 3 month, 6 month, 12 month, 24 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jane M Jacob, PhD, Synergy Spine Solutions
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
February 3, 2023
First Submitted That Met QC Criteria
February 13, 2023
First Posted (Actual)
February 22, 2023
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 15, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP 110-0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Degenerative Disc Disease
-
Medtronic Spinal and BiologicsCompletedDegenerative Cervical Disc DiseaseSaudi Arabia, Greece, Serbia, Hungary, Czech Republic, Kuwait, Poland, Slovakia
-
Assiut UniversityNot yet recruiting
-
DePuy InternationalTerminatedCervical Degenerative Disc DiseaseAustralia, Germany, Italy, Malaysia, Netherlands, Spain, United Kingdom
-
Assistance Publique - Hôpitaux de ParisTerminatedCervical Degenerative Disc Disease | Kyphosis | Lumbar Degenerative Disc DiseaseFrance
-
Orthofix Inc.TerminatedCervical Degenerative Disc DiseaseUnited States
-
Synergy Spine SolutionsMCRANot yet recruitingCervical Degenerative Disc DiseaseUnited Kingdom
-
Medtronic Spinal and BiologicsCompletedCervical Degenerative Disc DiseaseUnited States
-
NuVasiveCompletedCervical Degenerative Disc DiseaseUnited States
-
Alphatec Spine, Inc.Terminated
-
Synergy Spine SolutionsMCRAActive, not recruitingCervical Degenerative Disc DiseaseUnited States
Clinical Trials on Anterior Cervical Discectomy and Fusion
-
Valérie SchuermansRecruitingCervical Disc Disease | Cervical Fusion | Fusion of Spine | Cervical Spondylosis | Cervical Disc Herniation | Myelopathy Cervical | Cervical Disc Degeneration | Radiculopathy, Cervical | Myelopathy, Compressive | Radiculopathy, Cervical Region | Radiculopathy; in Spondylosis | Radiculopathy; in Intervertebral... and other conditionsNetherlands
-
Assiut UniversityCompletedSelective Nerve Root Block | Selective DiscectomyEgypt
-
LifeNet HealthCompletedMyelopathy | Cervical RadiculopathyUnited States
-
Zimmer BiometCompletedSymptomatic Cervical Disc DiseaseUnited States
-
Mesoblast, Ltd.CompletedSpinal Stenosis | Cervical Degenerative Disc Disease | Degenerative SpondylolisthesisUnited States
-
NuVasiveCompleted
-
Peking University People's HospitalNot yet recruitingCervical Disc Disease | Disk Degeneration
-
Second Affiliated Hospital, School of Medicine,...Recruiting