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.

{ "Mobi-C and ACDF for Two-Level Degenerative Disc Disease", "This study is looking at the safety and effectiveness of a new surgical approach for people with two-level degenerative disc disease (DDD) in their neck. This condition causes arm pain and/or nerve problems, sometimes with neck pain. The new approach, called a \"hybrid construct,\" involves using a Mobi-C artificial disc at one level and a spinal fusion (ACDF) at another level. Researchers will compare the success of this hybrid surgery to results from past studies where people had a two-level spinal fusion. You might be able to join if you are between 22 and 69 years old and have symptoms of two-level DDD. The study will measure overall success after 24 months.", "design": "This is a multi-center study where 97 patients will receive the hybrid surgery. There is no information provided about blinding or randomization.", "commitments": "You will receive the hybrid surgery and be followed for a minimum of 2 years. Specific details about visits, procedures, or tests are not specified in the trial record.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for a minimum of 2 years after the surgery to assess the overall success of the procedure.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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.

Recruiting

NAAges 22–69InterventionalTreatment

Highridge Medical

~97 participants

Updated 2025-01-27 on ClinicalTrials.gov

What's tested:One level Mobi-C and one level fusion

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Composite Success

Measured over 24 months

Conditions

Degenerative Disc Disease

NCT06485206

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Michigan Orthopaedic Surgeons
Southfield, Michiganstudy coordinator listed
Recruiting
University of California-Davis
Sacramento, Californiastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Monica Barascout, BA

[email protected]

1-720-894-9016

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

1\. Age 22 - 69 years. 2. Have symptoms of cervical degenerative disc disease (DDD) at two levels from C3 to T1 defined as intractable radiculopathy (arm pain and /or a neurological deficit) with or without neck pain or myelopathy due to a two-level abnormality localized to the level of the disc space.

Exclusion

1\. Symptomatic DDD or significant cervical spondylosis at more than two levels 2. Reported to have an active systemic infection or infection at the operative site 3. Previous trauma resulting in significant bony or disco-ligamentous cervical spine injury 4. More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions 5. Reported to have had any prior fusion or CDA surgery in the cervical spine 6. Axial neck pain only (no radicular or myelopathy symptoms) 7. Disc height ≤25% of the anterior-posterior width of the inferior vertebral body 8. Severe facet joint disease or degeneration; or evidence of symptomatic moderate to severe facet joint degeneration or disease where the investigator feels this is a major contributor to the patient's pain as diagnosed by injection and imaging 9. Marked cervical instability on resting lateral or flexion/extension radiographs demonstrated by:

Translation greater than 3.5mm, and/or

Greater than 11° angular difference to that of either adjacent level 10. Segmental angulation of greater than 11° at treatment or adjacent levels 11. Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease) 12. Reported to have osteoporosis (T-SCORE greater than -1.0). All patients 50 years and older, post-menstrual, and females with hysterectomies will undergo a DEXA scan or hologic sahara as part of the study enrollment procedures.

For patients less than 50 years of age, the Simple Calculated Osteoporosis Risk Estimation (SCORE) questionnaire will be used to screen patients for osteoporosis. Patients whose screening suggests risk will undergo a DEXA scan.

Patients will be excluded if the DEXA scan results indicate a T-SCORE worse than -1.0 13. Any disease, condition or surgery which might impair healing, such as: Diabetes mellitus requiring daily insulin management 14. Active malignancy 15. Known sensitivity or allergies to any of the materials used with any of devices in study (e.g., cobalt chromium, titanium, polyethylene, PEEK) 16. Reported pregnancy or nursing at time of enrollment 17. Reported to have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system 18. Congenital bony and/or spinal cord abnormalities that affect spinal stability 19. Reported to have diseases or conditions that would preclude accurate clinical evaluation (e.g. neuromuscular disorders) 20. Reported concomitant conditions requiring steroid treatment 21. Reported to be taking medications known to potentially interfere with bone/soft tissue healing, e.g., long term use of corticosteroids (this does not include inhalation medications for asthma) 22. Reported to have a current history of heavy smoking (no less than one pack of cigarettes per day) 23. Recent history (within previous six months) of chemical or alcohol dependence 24. Morbid obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI \> 35) 25. Participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery 26. Currently involved in spinal litigation or receiving Worker's Compensation related to neck or back pain which may influence the subjects reporting of symptoms 27. Reported to have mental illness or belongs to a vulnerable population as determined by the investigator (e.g., prisoner or developmentally disabled) that would compromise ability to provide informed consent or compliance with follow-up requirements 28. Reported to have an uncontrolled seizure disorder

What this trial measures

Composite Success24 months
Statistical analysis of the combination of four components of success: improvement in Neck Disability Scale scores, no device failures, no major complications resulting in reoperations, no major AEs

Trialytics