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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Hybrid Construct | Experimental | Primary hybrid surgery is when patients undergo CDA and ACDF at the same time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One level Mobi-C and one level fusion | Device | Cervical Disc Arthroplasty: • Mobi-C Fusion devices:
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Success | 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index (NDI) | The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. | 24 months |
| Visual Analogue Scale- Neck Pain |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalization | Clinical outcome | 6 weeks |
| Blood Loss | clinical outcome | 6 weeks |
Inclusion Criteria:
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.
3. Radiographic evidence of at least one of the following:
a. Spondylosis (defined by the presence of osteophytes or dark disc) on CT or MRI; or b. Disc height decreased by ≥1 mm when compared to adjacent levels on radiographic film, CT, or MRI; or c. Disc herniation on CT or MRI. Appropriate treatment for using an anterior surgical approach, including having no prior surgery at the operative levels and no prior cervical fusion or arthroplasty procedure.
4. Neck Disability Index Score of ≥15/50 or ≥30%. 5. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and analgesics) for:
Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or
Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.
6. Able and willing to comply with the Protocol, including ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits* and requirements of the Protocol 7. Written informed consent provided by subject or subject's legally authorized representative.
*Note that patients who live significant distances away from a treatment center are statistically likely to be present for treatment but are not likely to return for all follow-up visits. For this reason, patients who live over 150 miles from a treatment center are not eligible for treatment in this clinical study without prior approval from the study Sponsor.
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Barascout, BA | Contact | 1-720-894-9016 | monica.barascout@highridgemedical.com | |
| Alex Pawlowski | Contact | 1-720-894-9016 | alex.pawlowski@highridgemedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Davis | Recruiting | Sacramento | California | 95816 | United States |
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|
|
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain in the neck. |
| 24 months |
| Visual Analogue Scale- Arm Pain | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain in the arms. | 24 months |
| Muscle Strength | Clinical outcome | 24 months |
| Sensory Deficit | An assessment made by the surgeon with a neurological examination to determine if there is any change in sensation compared to the assessment before surgery. | 24 months |
| Neurological Deficit | An assessment made by the surgeon with a neurological examination to determine if there is any change in neurological function compared to the assessment before surgery. | 24 months |
| Adjacent Segment Degeneration | Radiological assessment using Kellgren-Lawrence classification system to measure degeneration occurring in levels around the operated spine. | 24 months |
| Heterotopic Ossification | Radiological assessment using McAfee to measure bony growth on areas of motion in the Mobi-C level of the operated spine. | 24 months |
| Subsidence | Radiographic outcome | 24 months |
| Segmental Range of Motion | Radiographic outcome | 24 months |
| C2-C7 range of motion | radiographic outcome | 24 months |
| radiolucency measure | radiographic outcome | 24 months |
| Patient Satisfaction Questionnaire | Self-reported questionnaire to assess patient satisfaction of the surgical treatment outcomes | 24 months |
| quality of life survey (SF-12) | Patient reported outcome measure | 24 months |
| Dysphagia | Dysphagia will be assessed using Functional Outcome Swallowing Scale (FOSS) | 24 months |
| Gait Analysis | Gait will be assessed by physician during neurological examination | 24 months |
| Operative Time | clinical outcome | intraoperative |
| Return to Work | Clinical outcome will be measured by patient self-report of time since surgery before returning to work measured in days. | 6 weeks |
| Headache Outcome (HIT-6) | patient reported outcome | 24 months |
| Michigan Orthopaedic Surgeons | Recruiting | Southfield | Michigan | 48033 | United States |
|
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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