Clinical trial NCT00292292: Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)
Official title: Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Disc Disease
Lead sponsor: SpinalMotion
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 514
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 Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.

Detailed description: The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.

Eligibility criteria: Inclusion Criteria Summary:

* Be between 18 and 60 years of age
* Have evidence of degenerative disc disease (DDD)
* History of back and/or radicular pain which is severe, ongoing and recurrent
* Minimum 6 month period of prior conservative care
* Moderate Oswestry Disability Index score
* Moderate pain score
* Be likely to return for all follow-up visits
* Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria Summary:

* Any back or leg pain of unknown origin
* Foot drop
* Previous trauma to the study treatment level with compression or bursting
* Previous retroperitoneal surgery
* Other spinal surgery at affected level except IDET, laminotomy
* Previous thoracic or lumbar fusion
* Documented abnormal abdominal vessel or muscular/fascial pathology or morphology
* Degenerative spondylolisthesis
* Ischemic (spondylolytic) spondylolisthesis
* Spondylitis
* Documented significant spinal, foraminal or lateral stenosis
* Severely reduced disc space height
* Documented presence of free nuclear fragment
* Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray
* Scoliosis of the lumbar spine
* Metabolic bone disease
* Active systemic infection
* Hepatitis
* Active malignancy or history of metastatic malignancy
* Any terminal or autoimmune disease
* Any other disease, condition or surgery which might impair healing
* Recent history of chemical or alcohol dependence
* Current or extended use of any drug known to interfere with bone or soft tissue healing
* Known metal allergy
* Morbid obesity
* Transitional vertebrae at level to be treated that has not clearly fused
* Currently a prisoner
* Currently involved in spinal litigation
* Currently experiencing an episode of major mental illness
* Pregnancy at time of enrollment, since this would contraindicate abdominal surgery
* Participation in another drug, diologic or medical trial within 30 days of study surgery
* Lives more than 300 miles from a study center or participation in any other investigational drug, biologic or medical device study.

Primary outcomes:
measure: Improvement in Oswestry Low Back Pain Disability Score at 24 months compared with baseline; no revision removal, supplemental fixation or device related reoperations and no major adverse event as defined by the study protocol
timeFrame: 24 months
Secondary outcomes:
measure: Maintenance or improvement in neurologic status
timeFrame: 24 months
measure: Pain improvement
timeFrame: 24 months
measure: Significant disc height increase
timeFrame: 24 months
measure: No displacement or migration of the device
timeFrame: 24 months
measure: Time to return to work
timeFrame: 24 months
measure: Time to recovery
timeFrame: 24 months
measure: Preservation of at least 4 degrees of motion in flexion/extension
timeFrame: 24 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Orthopedics and Sports Medicine
state: California
city: Encinitas
country: United States
facility: CORE Orthopaedic Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Oakland Regional Spine Surgery
state: California
city: San Bernardino
country: United States
facility: Loma Linda University
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: UCSF Dept. of Orthopaedic Surgery
state: California
city: Loveland
country: United States
facility: Rocky Mountain Associates in Orthopedic Medicine, P.C.
state: Colorado
city: Aurora
country: United States
facility: Illinois Neuro-Spine Center
state: Illinois
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: 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: Lockport
country: United States
facility: Buffalo Spine Surgery
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: Pittsburg
country: United States
facility: Univ. of Pittsburgh Medical Center
state: Pennsylvania
city: Plano
country: United States
facility: Texas Back Institute Clinical Research Organization
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: