M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study (NCT04982835) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
United States156 participantsStarted 2021-07-26
Plain-language summary
Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-Câ„¢ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
* Inadequate response to conservative medical care over a period of at least 6 weeks or have the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
* Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
* Neck or arm pain Visual Analog Scale Score ≥ 4 on a scale of 0 to 10
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study specific informed consent
* Skeletally mature and at least 18 years old but not older than 75 years old
Exclusion Criteria:
* More than two cervical levels requiring surgery, or two non-contiguous levels requiring surgery
* Previous anterior cervical spine surgery
* Axial neck pain as the solitary symptom
* Previous posterior cervical spine surgery (such as a posterior element decompression) that destabilizes the cervical spine
* Advanced cervical anatomical deformity (such as ankylosing spondylitis, scoliosis) at either of the operative levels or adjacent levels
* Symptomatic facet arthrosis…
What they're measuring
1
Functional Impairment - Neck Disability Index Score (NDI)