Clinical trial NCT00374413: Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)
Official title: Clinical Study Protocol for the Investigation of the Kineflex|C Spinal System - a Pivotal Study in Continued Access Stage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Disc Disease (DDD)
Keywords: DDD
artificial disc
Lead sponsor: SpinalMotion
Sponsor class: INDUSTRY
First posted: 2006-09-11
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline
timeFrame: 24 months
measure: No major device related adverse events
timeFrame: 24 months
Secondary outcomes:
measure: Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline
timeFrame: 24 months
measure: Time to recovery
timeFrame: 24 months
measure: Disc height at 24 months compared to baseline
timeFrame: 24 months
measure: Adjacent level deterioration at 24 months compared to baseline
timeFrame: 24 months
measure: Progressive facet disease at 24 months compared to baseline
timeFrame: 24months
measure: Displacement or migration of the device
timeFrame: 24 months
measure: Odom's Criteria
timeFrame: 24 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Orthopedics and Sports Medicine
state: California
city: Oakland
country: United States
facility: Kaiser Foundation Research Institute
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Loveland
country: United States
facility: Rocky Mountain Associates in Orthopedic Medicine, P.C.
state: Colorado
city: Atlanta
country: United States
facility: Emory Orthopaedics & Spine Center
state: Georgia
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Annapolis
country: United States
facility: Maryland Brain and Spine Center
state: Maryland
city: Towson
country: United States
facility: Orthopaedic Associates, P.A
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Reno
country: United States
facility: Sierra Regional Spine Institute
state: Nevada
city: Hamilton
country: United States
facility: Hamilton Orthopaedic Surgery and Sports Medicine
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New York
country: United States
facility: Manhattan Orthopaedics, P.C.
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates
state: North Carolina
city: Durham
country: United States
facility: Triangle Orthopaedic Associates, P.A.
state: North Carolina
city: Pittsburgh
country: United States
facility: Univ. of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Semmes-Murphy Clinic
state: Tennessee
city: Plano
country: United States
facility: Plano Orthopedic Sports Medicine & Spine Center
state: Texas
city: Plano
country: United States
facility: SpineMark CRO at Texas Back Institue
state: Texas
city: Tyler
country: United States
facility: Gordon Spine Associates
state: Texas
city: Kirkland
country: United States
facility: Orthopedics International Spine
state: Washington
Study officials:
affiliation: Medical Monitor
name: Fred Geisler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coric D, Guyer RD, Nunley PD, Musante D, Carmody C, Gordon C, Lauryssen C, Boltes MO, Ohnmeiss DD. Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc. J Neurosurg Spine. 2018 Mar;28(3):252-261. doi: 10.3171/2017.5.SPINE16824. Epub 2018 Jan 5.
citation: Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24.