Actively Recruiting
Evaluation of Safety and Effectiveness of Primary Hybrid Construct of Mobi-C and ACDF in the Treatment of Two-level Symptomatic Degenerative Disc Disease in the Cervical Spine.
Led by Highridge Medical · Updated on 2025-01-27
97
Participants Needed
2
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a prospective, multi-center cohort study of patients with two-level DDD implanted with CDA adjacent to ACDF (hybrid construct). The overall success of the hybrid procedure will be compared to 2-level ACDF historical controls from the Mobi-C IDE trial. 97 patients will receive the hybrid surgery and will be followed for a minimum of 2 years.
CONDITIONS
Official Title
Evaluation of Safety and Effectiveness of Primary Hybrid Construct of Mobi-C and ACDF in the Treatment of Two-level Symptomatic Degenerative Disc Disease in the Cervical Spine.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 to 69 years
- Symptoms of cervical degenerative disc disease at two levels from C3 to T1 with radiculopathy or myelopathy
- Radiographic evidence of spondylosis, disc height loss of at least 1 mm, or disc herniation at affected levels
- Neck Disability Index Score of 15/50 or higher
- Unresponsive to non-operative treatments for about six weeks or have progressive nerve symptoms
- Able and willing to comply with study protocol and follow-up visits
- Provided written informed consent
You will not qualify if you...
- Degenerative disc disease or significant cervical spondylosis at more than two levels
- Active systemic or operative site infection
- Previous major cervical spine trauma or surgery including fusion or cervical disc arthroplasty
- More than one immobile vertebral level between C1 and C7
- Axial neck pain only without radicular or myelopathy symptoms
- Disc height less than 25% of vertebral body width
- Severe facet joint disease or degeneration affecting pain
- Marked cervical instability or segmental angulation over specified limits
- Metabolic bone disease or osteoporosis (T-score worse than -1.0)
- Conditions impairing healing such as insulin-dependent diabetes mellitus
- Active malignancy
- Allergies to device materials (cobalt chromium, titanium, polyethylene, PEEK)
- Pregnancy or nursing
- Autoimmune diseases affecting musculoskeletal system
- Congenital spinal abnormalities affecting stability
- Neuromuscular disorders or conditions preventing accurate evaluation
- Conditions requiring steroid treatment or interfering medications
- Heavy smoking (one pack per day or more)
- Recent chemical or alcohol dependence
- Morbid obesity (BMI over 35)
- Participation in other investigational studies within 30 days before surgery
- Current involvement in spinal litigation or Workers' Compensation related to neck/back pain
- Mental illness or vulnerable populations impairing consent or compliance
- Uncontrolled seizure disorder
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of California-Davis
Sacramento, California, United States, 95816
Actively Recruiting
2
Michigan Orthopaedic Surgeons
Southfield, Michigan, United States, 48033
Actively Recruiting
Research Team
M
Monica Barascout, BA
CONTACT
A
Alex Pawlowski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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