Clinical trial NCT01905930: Post-Approval Clinical Trial of the PCM® Cervical Disc
Official title: A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness of the PCM® Cervical Disc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radiculopathy
Myelopathy
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.

Detailed description: A prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate.

All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study. All patients who are actively participating in the pivotal IDE study will be asked to participate in this study.

The study consists of follow-up periods only. The follow-up period will last for seven years from each patient's surgery date.

Eligibility criteria: Inclusion Criteria:

* Patients enrolled in the PCM Cervical Disc IDE clinical study
* Patients willing and able to give informed consent

Exclusion Criteria:

* Patients considered failure during the PCM Cervical Disc IDE clinical study
* Patients who were withdrawn during the PCM Cervical Disc IDE clinical study

Primary outcomes:
measure: Individual Patient Overall Success
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Spine Group Beverly Hills
state: California
city: Greenwood Village
country: United States
facility: Denver Spine
state: Colorado
city: Chicago
country: United States
facility: Midwest Orthopedic Associates at Rush
state: Illinois
city: Chicago
country: United States
facility: Chicago Back Institute
state: Illinois
city: Indianapolis
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Towson
country: United States
facility: Towson Orthopedic Associates
state: Maryland
city: Southfield
country: United States
facility: Wm. Beaumont Hospital
state: Michigan
city: Columbia
country: United States
facility: Columbia Orthopedic Research
state: Missouri
city: Lockport
country: United States
facility: Buffalo Spine Surgery
state: New York
city: Syracuse
country: United States
facility: Institute for Spine Care
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Neuroscience Specialists
state: Oklahoma
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Winchester
country: United States
facility: Virginia Brain and Spine
state: Virginia
city: Olympia
country: United States
facility: Olympia Othopaedic Associates
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Appleton
country: United States
facility: NeuroSpine Center of Wisconsin
state: Wisconsin
Study officials:
References: