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

Primary Purpose

Cervical Degenerative Disc Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior Cervical Discectomy and Fusion
Sponsored by
Synergy Spine Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Degenerative Disc Disease focused on measuring degenerative disc disease, cervical, artificial disc replacement, motion preservation, motion preservation disc, cervical TDR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Todd Lanman, MDRecruiting
  • Institute of Neuro InnovationRecruiting
  • Steamboat Orthopaedic and Spine InstituteRecruiting
  • Kennedy-White Orthopaedic Center
  • Indiana Spine GroupRecruiting
  • Michigan Orthopedic Surgeons
  • M3 Emerging Medical ResearchRecruiting
  • Summit SpineRecruiting
  • Austin NeurosurgeonsRecruiting
  • DFW Center for Spinal DisordersRecruiting
  • Texas Spine Care CenterRecruiting
  • The Disc Replacement CenterRecruiting
  • Atlantic Brain and Spine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Synergy Disc

Arm Description

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.

Outcomes

Primary Outcome Measures

NDI
≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline
Standardized Neurological Assessment Scales
Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
Secondary Surgical Intervention
No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index levels
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.

Secondary Outcome Measures

SF-36
Health Survey (SF-36) at baseline and at each follow-up time-point
VAS
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.
Patient Satisfaction
Patient Satisfaction Questionnaire
BZ Score
Bazaz Dysphagia Score at 24 months compared to baseline
Odom's Criteria
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.

Full Information

First Posted
February 3, 2023
Last Updated
September 8, 2023
Sponsor
Synergy Spine Solutions
Collaborators
MCRA
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1. Study Identification

Unique Protocol Identification Number
NCT05740176
Brief Title
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synergy Spine Solutions
Collaborators
MCRA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Degenerative Disc Disease
Keywords
degenerative disc disease, cervical, artificial disc replacement, motion preservation, motion preservation disc, cervical TDR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
multicenter, prospective, historically controlled
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Synergy Disc
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Anterior Cervical Discectomy and Fusion
Other Intervention Name(s)
ACDF
Intervention Description
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
Primary Outcome Measure Information:
Title
NDI
Description
≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline
Time Frame
24 month
Title
Standardized Neurological Assessment Scales
Description
Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
Time Frame
24 month
Title
Secondary Surgical Intervention
Description
No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index levels
Time Frame
24 month
Title
Device Related Adverse Event
Description
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event as adjudicated by the CEC.
Time Frame
24 month
Secondary Outcome Measure Information:
Title
SF-36
Description
Health Survey (SF-36) at baseline and at each follow-up time-point
Time Frame
pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Title
VAS
Description
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.
Time Frame
pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Title
Patient Satisfaction
Description
Patient Satisfaction Questionnaire
Time Frame
6 week, 3 month, 6 month, 12 month, 24 month
Title
BZ Score
Description
Bazaz Dysphagia Score at 24 months compared to baseline
Time Frame
6 week, 3 month, 6 month, 12 month, 24 month
Title
Odom's Criteria
Description
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.
Time Frame
6 week, 3 month, 6 month, 12 month, 24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane M Jacob, PhD
Phone
512-289-5370
Email
janejacob@synergyspinesolutions.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Beck
Phone
202-552-5800
Email
lbeck@mcra.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane M Jacob, PhD
Organizational Affiliation
Synergy Spine Solutions
Official's Role
Study Director
Facility Information:
Facility Name
Todd Lanman, MD
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Phillips
Email
research@spine.md
Facility Name
Institute of Neuro Innovation
City
Santa Monica
State/Province
California
ZIP/Postal Code
91304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Petros
Email
research@inifoundation.org
Facility Name
Steamboat Orthopaedic and Spine Institute
City
Steamboat Springs
State/Province
Colorado
ZIP/Postal Code
80487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Wiedel
Email
awiedel@steamboatortho.com
Facility Name
Kennedy-White Orthopaedic Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Wood
Email
swood@kwoc.net
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheetal Vinayek
Email
svinayek@indianaspinegroup.com
Facility Name
Michigan Orthopedic Surgeons
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Watterworth
Email
courtney.watterworth@corewellhealth.org
Facility Name
M3 Emerging Medical Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shandelle Parker
Email
sparker@wakeresearch.com
Facility Name
Summit Spine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Brown
Email
pacsean@gmail.com
Facility Name
Austin Neurosurgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Keswani
Email
robin@researchtex.com
Facility Name
DFW Center for Spinal Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Keswani
Email
robin@researchtex.com
Facility Name
Texas Spine Care Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Keswani
Email
robin@researchtex.com
Facility Name
The Disc Replacement Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Scarth
Email
veronicalscarth@centura.org
Facility Name
Atlantic Brain and Spine
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Martin
Email
meghan@brainspinesurgery.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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