PCM Cervical Disc System

NCT00578812 | Completed Phase 3 Results

• 1 other identifier: G040081
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 23

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.

Conditions

Radiculopathy; Myelopathy

Outcome Measures

Primary Outcomes (1)

• Individual Patient Overall Success

  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.

  24 Months

Secondary Outcomes (15)

• Neck Pain Visual Analog Scale

  24 Months

• Mean Neck Pain Visual Analog Scale

  24 Months

• Worst Arm Pain Visual Analog Scale

  24 Months

• Mean Worst Arm Pain Visual Analog Scale

  24 Months

• Clinically Significant Improvement on Neck Disability Index (NDI)

  24 Months

Study Arms (2)

PCM Cervical Disc - Investigational

EXPERIMENTAL

PCM Cervical Disc replacement at one level from C3 to T1

Device: PCM Cervical Disc

ACDF - Control Group

ACTIVE COMPARATOR

Anterior cervical discectomy and fusion (ACDF) at one level from C3 to T1

Device: Anterior Cervical Discectomy and Fusion (ACDF)

Interventions

Anterior Cervical Discectomy and Fusion (ACDF) DEVICE

Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1

ACDF - Control Group

PCM Cervical Disc DEVICE

PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1

PCM Cervical Disc - Investigational

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• NuVasive: lead

Study Sites (23)

Tower Orthopedics

Beverly Hills, California, 90211, United States

Location

Spine Group Beverly Hills

Beverly Hills, California, 90212, United States

Location

Denver Spine

Greenwood Village, Colorado, 80111, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Midwest Orthopedic Associates at Rush

Chicago, Illinois, 60612, United States

Location

Chicago Back Institute

Chicago, Illinois, 60625, United States

Location

Goodman Campbell Brain and Spine

Indianapolis, Indiana, 46260, United States

Location

Towson Orthopedic Associates

Towson, Maryland, 21204, United States

Location

Wm. Beaumont Hospital

Southfield, Michigan, 48034, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia Orthopedic Research

Columbia, Missouri, 65201, United States

Location

Buffalo Spine Surgery

Lockport, New York, 14094, United States

Location

Institute for Spine Care

Syracuse, New York, 13202, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

OrthoNeuro

Westerville, Ohio, 43054, United States

Location

Neuroscience Specialists

Oklahoma City, Oklahoma, 73120, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Neurosurgical Associates of San Antonio

San Antonio, Texas, 78229, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Virginia Brain and Spine

Winchester, Virginia, 22601, United States

Location

Olympia Othopaedic Associates

Olympia, Washington, 98502, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-1100, United States

Location

NeuroSpine Center of Wisconsin

Appleton, Wisconsin, 54913, United States

Location

Related Links

• NuVasive

MeSH Terms

Conditions

Radiculopathy; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Julie Pairamore, Sr. Manager, Clinical Affairs
• Organization: NuVasive, Inc

jpairamore@nuvasive.com

858-320-5258

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: January 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2014
• Last Updated: July 7, 2015
• Results First Posted: February 12, 2013

Record last verified: 2015-06

Locations

US (23)