Study Details
Testing M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion
(IRB#: IRB_00161627)
Anterior Cervical Discectomy and Fusion (ACDF) is minimal surgery to treat people with pain in areas such as the neck and/or arm. The M6-C Artificial Cervical Disc could be another option for treating this condition. This study will compare the 2 treatments for adults with this condition. The study wants to see if the M6-C Artificial Cervical Disc will help people and is safe. People in the study will have ACDF surgery as a treatment for their neck and/or arm pain by a neurosurgeon or orthopedic surgeon at a University of Utah Health facility. Participants will be followed afterward by the surgeon, their clinical team, and a study coordinator. This follow-up will be done to collect information on recovery, pain reduction, improvement of function, and other patient feedback about the ACDF surgery. The ACDF surgery information will then be compared to another group of patients at other sites who have the M6-C Artificial Cervical Disc instead of ACDF surgery. People in the study who have ACDF surgery will attend follow-up visits with the doctor for about 24 months and possibly up to 5 years.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 to 75 years old
- Neck and/or arm pain with at least 6 weeks of treatment without surgery
- Told to have neck surgery in specific places on the spine
- Do not have any autoimmune disorders, cancer, or diabetes that requires insulin (medication used to treat the condition)
Exclusion Criteria
- More than 2 specific places on the spine requiring surgery
- Prior spine surgery in specific areas
- Specific neck pain as the one symptom
- Bone diseases such as osteoporosis that impact spine surgery
- Pregnant or intend to become pregnant during the study
Will I be paid for my time?
Yes
IRB#: IRB_00161627
PI: Mark Mahan
Department: NEUROSURGERY
Approval Date: 2023-05-31 06:00:00
Specialties: Neurosurgery, Orthopaedic Surgery