A prospective, randomized clinical investigation of the Cervitech, Inc., porous coated motion(PCM) artificial disc for stabilization of the cervical spine between C3-4 and C7-T1
The purpose of this study is to determine the safety and effectiveness of the PCM (porous coated motion) cervical artificial disc. Patients may be eligible for participation in this clinical trial if they are candidates for a 1-level anterior cervical discectomy and fusion (ACDF) and meet the additional inclusion criteria and are void of any of the exclusion criteria. Patients who are enrolled in this clinical trial will undergo either an ACDF or placement of the PCM artificial cervical disc. Treatment is assigned randomly into 1 of the 2 treatment arms.
You may be eligible to participate in this study if you:
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Are between the ages of 18-65
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Are a candidate for a 1-level ACDF
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Have neck and arm pain that has failed to improve with nonsurgical treatment
You will be excluded from this study if you:
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Had previous spine surgery within the last 6 months
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Have insulin-dependent diabetes, moderate to severe osteoporosis, or severe arthritis requiring long-term steroid use
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Are unwilling or unable to return to Rush for the required follow-up visits
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.