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

Cervical Degenerative Disc Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740176
• Other study ID #: CP 110-0004
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Synergy Spine Solutions
• Contact: Jane M Jacob, PhD
• Phone: 512-289-5370
• Email: janejacob[@]synergyspinesolutions.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Austin Neurosurgeons	Austin	Texas
United States	Bone and Joint Clinic of Baton Rouge	Baton Rouge	Louisiana
United States	Todd Lanman, MD	Beverly Hills	California
United States	Indiana Spine Group	Carmel	Indiana
United States	Carolina NeuroSurgery and Spine Associates, PA	Charlotte	North Carolina
United States	M3 Emerging Medical Research	Durham	North Carolina
United States	DFW Center for Spinal Disorders	Fort Worth	Texas
United States	DOCS Health Management LLC	Los Angeles	California
United States	Yale University Neurosurgery	New Haven	Connecticut
United States	Precision Spine and Orthopaedic Associates, PA	Overland Park	Kansas
United States	Summit Spine	Portland	Oregon
United States	Atlantic Brain and Spine	Reston	Virginia
United States	Michigan Orthopedic Surgeons	Royal Oak	Michigan
United States	Texas Spine Care Center	San Antonio	Texas
United States	Institute of Neuro Innovation	Santa Monica	California
United States	Kennedy-White Orthopaedic Center	Sarasota	Florida
United States	Louisiana Spine Institute	Shreveport	Louisiana
United States	Steamboat Orthopaedic and Spine Institute	Steamboat Springs	Colorado
United States	Oregon Spine Care	Tualatin	Oregon
United States	The Disc Replacement Center	West Jordan	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Synergy Spine Solutions	MCRA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NDI	= 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline	24 month
Primary	Standardized Neurological Assessment Scales	Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline	24 month
Primary	Secondary Surgical Intervention	No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index levels	24 month
Primary	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	SF-36	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
Secondary	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.	pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Secondary	Patient Satisfaction	Patient Satisfaction Questionnaire	6 week, 3 month, 6 month, 12 month, 24 month
Secondary	BZ Score	Bazaz Dysphagia Score at 24 months compared to baseline	6 week, 3 month, 6 month, 12 month, 24 month
Secondary	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.	6 week, 3 month, 6 month, 12 month, 24 month