PCM Cervical Disc System

Phase 3

Completed

Conditions: Myelopathy
Radiculopathy

Interventions: Device: PCM Cervical Disc
Device: Anterior Cervical Discectomy and Fusion (ACDF)

Registration Number: NCT00578812

Lead Sponsor: NuVasive

Brief Summary: 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.

Detailed Description: 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.

Patients were evaluated before surgery, during the operation, immediately after surgery, and then at 6 weeks, 3 months, 6 months, 12 months and 24 months, and yearly after surgery. The patients were recommended to have a physical therapy program for non-impact exercises and active range of motion exercises after surgery. Patients were also instructed to avoid repetitive cervical flexion and extension bending and lateral bending and rotation for 6 weeks following surgery.

The safety of the PCM Cervical Disc was assessed by comparing the adverse events, any additional surgical procedures, and the neurological outcomes to those in the ACDF control group. The effectiveness of the PCM Cervical Disc was assessed by evaluating patients' pain and function outcomes using a standard questionnaire, the Neck Disability Index (NDI), the severity of neck and arm pain based on a Visual Analog Scale (VAS) assessment, quality of life using a standard questionnaire, the Short Form-36 (SF-36), as well as a patient satisfaction questionnaire compared to the ACDF control group. In addition, the patients were evaluated using radiographic evaluations, including spinal range of motion, spinal disc height, device displacement or migration, spinal fusion status, and heterotopic ossification (abnormal bone formation).

The primary endpoint of the IDE trial was a composite measure termed "overall success," which was evaluated at 24 months postoperatively, and was defined as at least 20% improvement in neck disability index (NDI) from preoperative score; absence of reoperation, revision, or removal; maintenance or improvement in neurological status; and absence of radiographic or major complications during the 24-month follow-up period.

On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 494

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCM Cervical Disc - Investigational	PCM Cervical Disc	PCM Cervical Disc replacement at one level from C3 to T1
ACDF - Control Group	Anterior Cervical Discectomy and Fusion (ACDF)	Anterior cervical discectomy and fusion (ACDF) at one level from C3 to T1

Primary Outcome Measures

Name	Time	Method
Individual Patient Overall Success	24 Months	Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.

Secondary Outcome Measures

Name	Time	Method
Neck Pain Visual Analog Scale	24 Months	Improvement of ≥20mm in neck pain at 24 months compared to baseline.
Mean Worst Arm Pain Visual Analog Scale	24 Months	Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).
Mean Neck Disability Index (NDI)	24 Months	Mean NDI at 24 months on a 0-100 scale (lower value is better).
Mean SF-36 Physical Component Summary (PCS)	24 Months	Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).
Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)	24 Months	Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.
Worst Arm Pain Visual Analog Scale	24 Months	Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.
Dysphagia for Swallowing	24 Months	Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).
Mean Neck Pain Visual Analog Scale	24 Months	Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).
Clinically Significant Improvement on Neck Disability Index (NDI)	24 Months	Improvement in NDI of ≥15-points at 24 months compared to baseline.
Patient Satisfaction	24 Months	Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).
Flexion/Extension Range of Motion at the Operative Level	24 Months	Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.
Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)	24 Months	Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.
Mean SF-36 Mental Component Summary (MCS)	24 Months	Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).
Nurick's Classification of Disability (Myelopathy)	24 Months	Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick's classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient "maintained" if their Nurick classification grade remained the same or "improved" if it decreased from baseline to 24 months.

Trial Locations

Locations (23): Midwest Orthopedic Associates at Rush
🇺🇸
Chicago, Illinois, United States
Buffalo Spine Surgery
🇺🇸
Lockport, New York, United States
The Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
The Rothman Institute
🇺🇸
Philadelphia, Pennsylvania, United States
Walter Reed Army Medical Center
🇺🇸
Washington, DC, District of Columbia, United States
Wm. Beaumont Hospital
🇺🇸
Southfield, Michigan, United States
Institute for Spine Care
🇺🇸
Syracuse, New York, United States
Madigan Army Medical Center
🇺🇸
Tacoma, Washington, United States
Virginia Brain and Spine
🇺🇸
Winchester, Virginia, United States
Olympia Othopaedic Associates
🇺🇸
Olympia, Washington, United States
Goodman Campbell Brain and Spine
🇺🇸
Indianapolis, Indiana, United States
Towson Orthopedic Associates
🇺🇸
Towson, Maryland, United States
Chicago Back Institute
🇺🇸
Chicago, Illinois, United States
Spine Group Beverly Hills
🇺🇸
Beverly Hills, California, United States
Tower Orthopedics
🇺🇸
Beverly Hills, California, United States
Denver Spine
🇺🇸
Greenwood Village, Colorado, United States
Columbia Orthopedic Research
🇺🇸
Columbia, Missouri, United States
OrthoNeuro
🇺🇸
Westerville, Ohio, United States
NeuroSpine Center of Wisconsin
🇺🇸
Appleton, Wisconsin, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Neuroscience Specialists
🇺🇸
Oklahoma City, Oklahoma, United States
Neurosurgical Associates of San Antonio
🇺🇸
San Antonio, Texas, United States
Scott and White Memorial Hospital
🇺🇸
Temple, Texas, United States