Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
494 participants
INTERVENTIONAL
2013-04-30
2015-04-30
Brief Summary
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The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PCM Cervical Disc
Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1
PCM Cervical Disc
Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1
Ant. Cervical Discectomy & Fusion(ACDF)
Patients enrolled in the IDE clinical study and treated with an 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
Anterior Cervical Discectomy and Fusion (ACDF)
Patients enrolled in the IDE clinical study and treated with an 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
Interventions
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PCM Cervical Disc
Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1
Anterior Cervical Discectomy and Fusion (ACDF)
Patients enrolled in the IDE clinical study and treated with an 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
Eligibility Criteria
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Inclusion Criteria
* Patients willing and able to give informed consent
Exclusion Criteria
* Patients who were withdrawn during the PCM Cervical Disc IDE clinical study
18 Years
65 Years
ALL
No
Sponsors
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NuVasive
INDUSTRY
Responsible Party
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Locations
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Spine Group Beverly Hills
Beverly Hills, California, United States
Denver Spine
Greenwood Village, Colorado, 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
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
Neuroscience Specialists
Oklahoma City, Oklahoma, United States
The Rothman Institute
Philadelphia, Pennsylvania, 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
Countries
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Related Links
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Related Info
Other Identifiers
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NUVA-PCM-1101
Identifier Type: -
Identifier Source: org_study_id
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