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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ACTIVE_NOT_RECRUITING
152 participants
OBSERVATIONAL
2019-11-30
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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M6-C
Subjects treated with an M6-C device
standard radiographic imaging
standard radiographic imaging
cervical total disc replacement
Artificial disc replacement (ADR) in the cervical spine is a minimally invasive procedure that involves removing diseased disc tissue and replacing it with an artificial disc. The artificial disc is designed to preserve the spine\'s natural motion while remaining securely attached to the surrounding vertebral bones. The goal of ADR is to help preserve the motion of the cervical spine or spinal segment after surgery, which can improve the quality of life for patients.
ACDF
Subjects treated with Anterior Cervical Discectomy and Fusion (ACDF)
standard radiographic imaging
standard radiographic imaging
Interventions
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standard radiographic imaging
standard radiographic imaging
cervical total disc replacement
Artificial disc replacement (ADR) in the cervical spine is a minimally invasive procedure that involves removing diseased disc tissue and replacing it with an artificial disc. The artificial disc is designed to preserve the spine\'s natural motion while remaining securely attached to the surrounding vertebral bones. The goal of ADR is to help preserve the motion of the cervical spine or spinal segment after surgery, which can improve the quality of life for patients.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance)
* Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS
21 Years
68 Years
ALL
No
Sponsors
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Spinal Kinetics
INDUSTRY
Responsible Party
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Locations
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Desert Institute for Spine Care
Phoenix, Arizona, United States
The CORE Institute
Sun City West, Arizona, United States
Spine MD
Beverly Hills, California, United States
Memorial Orthopedic Surgical Group
Long Beach, California, United States
Stanford University
Stanford, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
ClinTech Center for Spine
Johnstown, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Medstar Hospital/Georgetown University
Washington D.C., District of Columbia, United States
Midwest Orthopedics
Chicago, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Spine Institute of Lousianna
Shreveport, Louisiana, United States
HSS
New York, New York, United States
Upstate Medical University
Syracuse, New York, United States
CNSA
Charlotte, North Carolina, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, United States
EmergeOrtho
Durham, North Carolina, United States
The Ohio State University - Wexner Medical Center
Columbus, Ohio, United States
Center for Sports Medicine & Orthopedics
Chattanooga, Tennessee, United States
Texas Back Institute
Plano, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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CA-C004
Identifier Type: -
Identifier Source: org_study_id
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