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

Primary Purpose

Degenerative Disc Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar Artificial Disc
Charite Artificial Disc
Sponsored by
SpinalMotion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tower Orthopedics and Sports Medicine
  • CORE Orthopaedic Medical Center
  • Kaiser Oakland Regional Spine Surgery
  • Loma Linda University
  • University of California San Diego
  • UCSF Dept. of Orthopaedic Surgery
  • Rocky Mountain Associates in Orthopedic Medicine, P.C.
  • Illinois Neuro-Spine Center
  • Spine Institute of Louisiana
  • Maryland Brain and Spine Center
  • Orthopaedic Associates, P.A
  • Sierra Regional Spine Institute
  • Hamilton Orthopaedic Surgery and Sports Medicine
  • Buffalo Spine Surgery
  • Manhattan Orthopaedics, P.C.
  • Carolina Neurosurgery and Spine Associates
  • Triangle Orthopaedic Associates, P.A.
  • Univ. of Pittsburgh Medical Center
  • Texas Back Institute Clinical Research Organization
  • Gordon Spine Associates
  • Orthopedics International Spine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kineflex Lumbar Artificial Disc

Charite

Arm Description

Treatment arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maintenance or improvement in neurologic status
Pain improvement
Significant disc height increase
No displacement or migration of the device
Time to return to work
Time to recovery
Preservation of at least 4 degrees of motion in flexion/extension

Full Information

First Posted
February 13, 2006
Last Updated
August 31, 2013
Sponsor
SpinalMotion
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1. Study Identification

Unique Protocol Identification Number
NCT00292292
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Economic and business reasons
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SpinalMotion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kineflex Lumbar Artificial Disc
Arm Type
Experimental
Arm Description
Treatment arm
Arm Title
Charite
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Lumbar Artificial Disc
Other Intervention Name(s)
Kineflex Disc
Intervention Description
Insertion of the Kineflex Lumbar ArtificialDisc
Intervention Type
Device
Intervention Name(s)
Charite Artificial Disc
Other Intervention Name(s)
SB Charite
Intervention Description
Insertion of the Charite
Primary Outcome Measure Information:
Title
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Maintenance or improvement in neurologic status
Time Frame
24 months
Title
Pain improvement
Time Frame
24 months
Title
Significant disc height increase
Time Frame
24 months
Title
No displacement or migration of the device
Time Frame
24 months
Title
Time to return to work
Time Frame
24 months
Title
Time to recovery
Time Frame
24 months
Title
Preservation of at least 4 degrees of motion in flexion/extension
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Geisler, MD
Organizational Affiliation
Medical Monitor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tower Orthopedics and Sports Medicine
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
CORE Orthopaedic Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Kaiser Oakland Regional Spine Surgery
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Loma Linda University
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF Dept. of Orthopaedic Surgery
City
San Francisco
State/Province
California
ZIP/Postal Code
94122
Country
United States
Facility Name
Rocky Mountain Associates in Orthopedic Medicine, P.C.
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Illinois Neuro-Spine Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Maryland Brain and Spine Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Orthopaedic Associates, P.A
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Sierra Regional Spine Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Hamilton Orthopaedic Surgery and Sports Medicine
City
Hamilton
State/Province
New York
ZIP/Postal Code
13346
Country
United States
Facility Name
Buffalo Spine Surgery
City
Lockport
State/Province
New York
ZIP/Postal Code
14094
Country
United States
Facility Name
Manhattan Orthopaedics, P.C.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolina Neurosurgery and Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Triangle Orthopaedic Associates, P.A.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Univ. of Pittsburgh Medical Center
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Texas Back Institute Clinical Research Organization
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Gordon Spine Associates
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Orthopedics International Spine
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.spinalmotion.com
Description
sponsors web site contains animated information regarding disc

Learn more about this trial

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

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