Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)

Degenerative Disc Disease Clinical Trial

Official title:

Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00292292
• Other study ID #: Kineflex
• Status: Terminated
• Phase: N/A
• First received: February 13, 2006
• Last updated: August 31, 2013
• Start date: January 2005
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: SpinalMotion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 514
• Est. completion date: August 2013
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• Lumbar Artificial Disc
Insertion of the Kineflex Lumbar ArtificialDisc
• Charite Artificial Disc
Insertion of the Charite

Locations

Country	Name	City	State
United States	Maryland Brain and Spine Center	Annapolis	Maryland
United States	Illinois Neuro-Spine Center	Aurora	Illinois
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	CORE Orthopaedic Medical Center	Encinitas	California
United States	Hamilton Orthopaedic Surgery and Sports Medicine	Hamilton	New York
United States	Orthopedics International Spine	Kirkland	Washington
United States	Buffalo Spine Surgery	Lockport	New York
United States	Rocky Mountain Associates in Orthopedic Medicine, P.C.	Loveland	Colorado
United States	Manhattan Orthopaedics, P.C.	New York	New York
United States	Kaiser Oakland Regional Spine Surgery	Oakland	California
United States	Univ. of Pittsburgh Medical Center	Pittsburg	Pennsylvania
United States	Texas Back Institute Clinical Research Organization	Plano	Texas
United States	Sierra Regional Spine Institute	Reno	Nevada
United States	Loma Linda University	San Bernardino	California
United States	University of California San Diego	San Diego	California
United States	UCSF Dept. of Orthopaedic Surgery	San Francisco	California
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Orthopaedic Associates, P.A	Towson	Maryland
United States	Gordon Spine Associates	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
SpinalMotion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 months	Yes
Secondary	Maintenance or improvement in neurologic status		24 months	Yes
Secondary	Pain improvement		24 months	No
Secondary	Significant disc height increase		24 months	No
Secondary	No displacement or migration of the device		24 months	Yes
Secondary	Time to return to work		24 months	No
Secondary	Time to recovery		24 months	No
Secondary	Preservation of at least 4 degrees of motion in flexion/extension		24 months	No