PCM Cervical Disc System

Completed · Phase 3

Conditions studied: Radiculopathy, Myelopathy

In brief

The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.

Key facts

Study ID

NCT00578812

Run by

NuVasive

People needed

494

Starts

2005-01-01

Expected to finish

2014-08-01

Last updated by the study team

2015-07-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65 years;
• Diagnosis of radiculopathy or myelopathy of the cervical spine between C3-4 and C7-T1;
• Symptomatic at only one level from C3-C4 to C7-T1;
• Unresponsive to non-operative treatment for six weeks, or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment;
• Baseline NDI score of ≥30/100;
• Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following: decreased disc height, degenerative spondylosis on CT or MRI, or disc herniation;
• Appropriate for treatment using an anterior surgical approach, including having no more than one previous anterior surgical approach to the cervical spine;
• Ability and willingness to comply with follow-up regimen; and
• Written informed consent given by subject or subject's legally authorized representative.

You may not qualify if…

• Infection at the site of surgery;
• History of, or anticipated treatment for, active systemic infection, including HIV infection or hepatitis C;
• Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion;
• More than one immobile vertebral level between C1-T1 from any cause, including but not limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior cervical spinal fusions;
• Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous cervical spine injury;
• Axial neck pain in the absence of other symptoms of radiculopathy or myelopathy justifying the need for surgical intervention;
• Radiographic confirmation of severe facet joint disease or degeneration.
• Osteoporosis:
• Severe diabetes mellitus requiring daily insulin management;
• Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
• Tumor as source of symptoms;
• Symptomatic DDD or significant cervical spondylosis at two or more levels;
• Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;
• Severe myelopathy to the extent that the patient is wheelchair bound;
• Pregnant (verified in patients of childbearing potential by a negative urine pregnancy test when preadmission testing is obtained), or interested in becoming pregnant during the duration of the study;
• Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis);
• Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration is likely anticipated within 6 months after the cervical randomized procedure;
• Other degenerative joint disease (e.g. shoulder, hip, knee) to the extent that surgical consideration is likely anticipated within 6 months after the cervical randomized procedure;
• Previous spine surgery within the 6 months preceding the cervical randomized procedure;
• Current or recent history of substance abuse (drug or alcohol);
• Morbid obesity, defined as body mass index ("BMI") > 40 or more than 100 lbs. over ideal body weight;
• Currently using, or planning to use, bone growth stimulators in the cervical spine;
• Use of any other investigational drug or medical device within the last 30 days prior to surgery
• Currently a prisoner; or
• Currently pursuing personal litigation related to the neck or cervical spine injury; however, involvement in worker's compensation related litigation is not a required exclusion.

Where it is running

• Tower Orthopedics — Beverly Hills, California, United States
• Spine Group Beverly Hills — Beverly Hills, California, United States
• Denver Spine — Greenwood Village, Colorado, United States
• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Midwest Orthopedic Associates at Rush — Chicago, Illinois, United States
• Chicago Back Institute — Chicago, Illinois, United States
• Goodman Campbell Brain and Spine — Indianapolis, Indiana, United States
• Towson Orthopedic Associates — Towson, Maryland, United States
• Wm. Beaumont Hospital — Southfield, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia Orthopedic Research — Columbia, Missouri, United States
• Buffalo Spine Surgery — Lockport, New York, United States
• Institute for Spine Care — Syracuse, New York, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• OrthoNeuro — Westerville, Ohio, United States
• Neuroscience Specialists — Oklahoma City, Oklahoma, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States
• Neurosurgical Associates of San Antonio — San Antonio, Texas, United States
• Scott and White Memorial Hospital — Temple, Texas, United States
• Virginia Brain and Spine — Winchester, Virginia, United States
• Olympia Othopaedic Associates — Olympia, Washington, United States
• Madigan Army Medical Center — Tacoma, Washington, United States
• NeuroSpine Center of Wisconsin — Appleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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