Degenerative Disc Disease (DDD) Clinical Trial
Official title:
Clinical Study Protocol for the Investigation of the Kineflex|C Spinal System - a Pivotal Study in Continued Access Stage
Verified date | August 2013 |
Source | SpinalMotion |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 343 |
Est. completion date | August 2013 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Maryland Brain and Spine Center | Annapolis | Maryland |
United States | Emory Orthopaedics & Spine Center | Atlanta | Georgia |
United States | Tower Orthopedics and Sports Medicine | Beverly Hills | California |
United States | Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina |
United States | Triangle Orthopaedic Associates, P.A. | Durham | North Carolina |
United States | Hamilton Orthopaedic Surgery and Sports Medicine | Hamilton | New York |
United States | Orthopedics International Spine | Kirkland | Washington |
United States | Rocky Mountain Associates in Orthopedic Medicine, P.C. | Loveland | Colorado |
United States | Semmes-Murphy Clinic | Memphis | Tennessee |
United States | Northern Westchester Hospital | Mount Kisco | New York |
United States | Manhattan Orthopaedics, P.C. | New York | New York |
United States | Kaiser Foundation Research Institute | Oakland | California |
United States | Univ. of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Plano Orthopedic Sports Medicine & Spine Center | Plano | Texas |
United States | SpineMark CRO at Texas Back Institue | Plano | Texas |
United States | Sierra Regional Spine Institute | Reno | Nevada |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | University of California San Diego | San Diego | California |
United States | Spine Institute of Louisiana | Shreveport | Louisiana |
United States | Orthopaedic Associates, P.A | Towson | Maryland |
United States | Gordon Spine Associates | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
SpinalMotion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline | 24 months | No | |
Primary | No major device related adverse events | 24 months | Yes | |
Secondary | Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline | 24 months | No | |
Secondary | Time to recovery | 24 months | No | |
Secondary | Disc height at 24 months compared to baseline | 24 months | No | |
Secondary | Adjacent level deterioration at 24 months compared to baseline | 24 months | No | |
Secondary | Progressive facet disease at 24 months compared to baseline | 24months | No | |
Secondary | Displacement or migration of the device | 24 months | Yes | |
Secondary | Odom's Criteria | 24 months | No |
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