Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)

Not Applicable

Terminated

Conditions: Degenerative Disc Disease (DDD)

Interventions: Device: Artificial disk
Device: Artificial disc

Registration Number: NCT00374413

Lead Sponsor: SpinalMotion

Brief Summary: The purpose of this study is to show that the Kineflex\|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.

Detailed Description: The Kineflex\|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two foot print sizes.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 343

Inclusion Criteria

have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI;
have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms;
have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression;
have moderate disability neck disability index (NDI) score; AND
be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation

Exclusion Criteria

marked cervical instability;
non discogenic neck pain or non discogenic source of symptoms;
radiographic confirmation of severe facet disease or facet degeneration;
bridging osteophytes;
prior surgery at the level to be treated;
prior fusion at any cervical level;
more than one neck surgery via anterior approach;
previous trauma to the C3-C7 levels resulting in compression or bursting;
documented presence of free nuclear fragment at any cervical level;
severe myelopathy;
any paralysis;
history of chemical or alcohol dependence;
active systemic infection;
infection at the site of surgery;
prior disc space infection or osteomyelitis in the cervical spine;
any terminal, systemic or autoimmune disease;
metabolic bone disease (e.g., osteoporosis, gout, osteomalacia, Paget's disease);
any disease, condition or surgery which might impair healing;
known metal allergy;
arachnoiditis;
currently experiencing an episode of major mental illness;
pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery;
morbid obesity; use of spinal stimulator at any cervical level prior to surgery;
currently a prisoner;
currently involved in spinal litigation which may influence the subjects reporting of symptoms; OR
lives more than 300 miles from study center or participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACDF	Artificial disc	-
ACDF	Artificial disk	-
Kineflex-C	Artificial disk	-
Kineflex-C	Artificial disc	-

Primary Outcome Measures

Name	Time	Method
Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline	24 months
No major device related adverse events	24 months

Secondary Outcome Measures

Name	Time	Method
Disc height at 24 months compared to baseline	24 months
Displacement or migration of the device	24 months
Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline	24 months
Time to recovery	24 months
Adjacent level deterioration at 24 months compared to baseline	24 months
Odom's Criteria	24 months
Progressive facet disease at 24 months compared to baseline	24months

Trial Locations

Locations (21): Univ. of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Kaiser Foundation Research Institute
🇺🇸
Oakland, California, United States
Rocky Mountain Associates in Orthopedic Medicine, P.C.
🇺🇸
Loveland, Colorado, United States
Sierra Regional Spine Institute
🇺🇸
Reno, Nevada, United States
University of California San Diego
🇺🇸
San Diego, California, United States
Maryland Brain and Spine Center
🇺🇸
Annapolis, Maryland, United States
Orthopaedic Associates, P.A
🇺🇸
Towson, Maryland, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Semmes-Murphy Clinic
🇺🇸
Memphis, Tennessee, United States
Tower Orthopedics and Sports Medicine
🇺🇸
Beverly Hills, California, United States
Emory Orthopaedics & Spine Center
🇺🇸
Atlanta, Georgia, United States
Spine Institute of Louisiana
🇺🇸
Shreveport, Louisiana, United States
Hamilton Orthopaedic Surgery and Sports Medicine
🇺🇸
Hamilton, New York, United States
Northern Westchester Hospital
🇺🇸
Mount Kisco, New York, United States
Manhattan Orthopaedics, P.C.
🇺🇸
New York, New York, United States
Carolina Neurosurgery and Spine Associates
🇺🇸
Charlotte, North Carolina, United States
Triangle Orthopaedic Associates, P.A.
🇺🇸
Durham, North Carolina, United States
Plano Orthopedic Sports Medicine & Spine Center
🇺🇸
Plano, Texas, United States
Gordon Spine Associates
🇺🇸
Tyler, Texas, United States
SpineMark CRO at Texas Back Institue
🇺🇸
Plano, Texas, United States
Orthopedics International Spine
🇺🇸
Kirkland, Washington, United States