Clinical trial NCT05740176: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Degenerative Disc Disease
Keywords: degenerative disc disease
cervical
artificial disc replacement
motion preservation
motion preservation disc
cervical TDR
Lead sponsor: Synergy Spine Solutions
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2023-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multicenter, prospective, historically controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: NDI
timeFrame: 24 month
measure: Standardized Neurological Assessment Scales
timeFrame: 24 month
measure: Secondary Surgical Intervention
timeFrame: 24 month
measure: Device Related Adverse Event
timeFrame: 24 month
Secondary outcomes:
measure: SF-36
timeFrame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
measure: VAS
timeFrame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
measure: Patient Satisfaction
timeFrame: 6 week, 3 month, 6 month, 12 month, 24 month
measure: BZ Score
timeFrame: 6 week, 3 month, 6 month, 12 month, 24 month
measure: Odom's Criteria
timeFrame: 6 week, 3 month, 6 month, 12 month, 24 month
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Todd Lanman, MD
state: California
city: Los Angeles
country: United States
facility: DOCS Health Management LLC
state: California
city: Santa Monica
country: United States
facility: Institute of Neuro Innovation
state: California
city: Steamboat Springs
country: United States
facility: Steamboat Orthopaedic and Spine Institute
state: Colorado
city: Delray Beach
country: United States
facility: Brain and Spine Center of South Florida
state: Florida
city: Sarasota
country: United States
facility: Kennedy-White Orthopaedic Center
state: Florida
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Fort Wayne
country: United States
facility: Orthopedics Northeast
state: Indiana
city: Overland Park
country: United States
facility: Precision Spine and Orthopaedic Associates, PA
state: Kansas
city: Baton Rouge
country: United States
facility: Bone and Joint Clinic of Baton Rouge
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Spine Institute
state: Louisiana
city: Royal Oak
country: United States
facility: Michigan Orthopedic Surgeons
state: Michigan
city: Charlotte
country: United States
facility: Carolina NeuroSurgery and Spine Associates, PA
state: North Carolina
city: Durham
country: United States
facility: M3 Emerging Medical Research
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Surgical Clinic
state: North Carolina
city: Portland
country: United States
facility: Summit Spine
state: Oregon
city: Tualatin
country: United States
facility: Oregon Spine Care
state: Oregon
city: Austin
country: United States
facility: Austin Neurosurgeons
state: Texas
city: Fort Worth
country: United States
facility: DFW Center for Spinal Disorders
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: San Antonio
country: United States
facility: Texas Spine Care Center
state: Texas
city: West Jordan
country: United States
facility: The Disc Replacement Center
state: Utah
city: Reston
country: United States
facility: Atlantic Brain and Spine
state: Virginia
Study officials:
affiliation: Synergy Spine Solutions
name: Jane M Jacob, PhD
role: STUDY_DIRECTOR
References: