A Clinical Investigation Evaluating 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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 69
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California-Davis
RECRUITING
Sacramento
Michigan
Michigan Orthopaedic Surgeons
RECRUITING
Southfield
Contact Information
Primary
Monica Barascout, BA
monica.barascout@highridgemedical.com
1-720-894-9016
Backup
Alex Pawlowski
alex.pawlowski@highridgemedical.com
1-720-894-9016
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2029-05
Participants
Target number of participants: 97
Treatments
Experimental: Primary Hybrid Construct
Primary hybrid surgery is when patients undergo CDA and ACDF at the same time.
Related Therapeutic Areas
Sponsors
Leads: Highridge Medical

This content was sourced from clinicaltrials.gov