Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)
This study is ongoing, but not recruiting participants.
Sponsor:
SpinalMotion
Information provided by:
SpinalMotion
ClinicalTrials.gov Identifier:
NCT00292292
First received: February 13, 2006
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Degenerative Disc Disease |
Device: Lumbar Artificial Disc Device: Charite Artificial Disc |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage |
Further study details as provided by SpinalMotion:
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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Maintenance or improvement in neurologic status [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Pain improvement [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Significant disc height increase [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- No displacement or migration of the device [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Time to return to work [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to recovery [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Preservation of at least 4 degrees of motion in flexion/extension [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 514 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | March 2015 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Kineflex Lumbar Artificial Disc
Treatment arm
|
Device: Lumbar Artificial Disc
Insertion of the Kineflex Lumbar ArtificialDisc
Other Name: Kineflex Disc
|
| Active Comparator: Charite |
Device: Charite Artificial Disc
Insertion of the Charite
Other Name: SB Charite
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292292
Locations
| United States, California | |
| Tower Orthopedics and Sports Medicine | |
| Beverly Hills, California, United States, 90211 | |
| CORE Orthopaedic Medical Center | |
| Encinitas, California, United States, 92024 | |
| Kaiser Oakland Regional Spine Surgery | |
| Oakland, California, United States, 94611 | |
| Loma Linda University | |
| San Bernardino, California, United States, 92408 | |
| University of California San Diego | |
| San Diego, California, United States, 92103 | |
| UCSF Dept. of Orthopaedic Surgery | |
| San Francisco, California, United States, 94122 | |
| United States, Colorado | |
| Rocky Mountain Associates in Orthopedic Medicine, P.C. | |
| Loveland, Colorado, United States, 80538 | |
| United States, Illinois | |
| Illinois Neuro-Spine Center | |
| Aurora, Illinois, United States, 60504 | |
| United States, Louisiana | |
| Spine Institute of Louisiana | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Maryland | |
| Maryland Brain and Spine Center | |
| Annapolis, Maryland, United States, 21401 | |
| Orthopaedic Associates, P.A | |
| Towson, Maryland, United States, 21204 | |
| United States, Nevada | |
| Sierra Regional Spine Institute | |
| Reno, Nevada, United States, 89509 | |
| United States, New York | |
| Hamilton Orthopaedic Surgery and Sports Medicine | |
| Hamilton, New York, United States, 13346 | |
| Buffalo Spine Surgery | |
| Lockport, New York, United States, 14094 | |
| Manhattan Orthopaedics, P.C. | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Carolina Neurosurgery and Spine Associates | |
| Charlotte, North Carolina, United States, 28204 | |
| Triangle Orthopaedic Associates, P.A. | |
| Durham, North Carolina, United States, 27704 | |
| United States, Pennsylvania | |
| Univ. of Pittsburgh Medical Center | |
| Pittsburg, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Texas Back Institute Clinical Research Organization | |
| Plano, Texas, United States, 75093 | |
| Gordon Spine Associates | |
| Tyler, Texas, United States, 75701 | |
| United States, Washington | |
| Orthopedics International Spine | |
| Kirkland, Washington, United States, 98034 | |
Sponsors and Collaborators
SpinalMotion
Investigators
| Principal Investigator: | Fred Geisler, MD | Medical Monitor |
More Information
Additional Information:
No publications provided
| Responsible Party: | VP Regulatory & Clinical Affairs, SpinalMotion |
| ClinicalTrials.gov Identifier: | NCT00292292 History of Changes |
| Other Study ID Numbers: | Kineflex |
| Study First Received: | February 13, 2006 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Spinal Diseases Intervertebral Disk Degeneration Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013