Degenerative Disc DiseaseNCT00292292
Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)
A study testing Lumbar Artificial Disc and Charite Artificial Disc in people with Degenerative Disc Disease, run by SpinalMotion at 21 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Lumbar Artificial Disc and Charite Artificial Disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 21 sitesUnited States
- Study dates
- Jan 2005to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 32Show fewer
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Maryland Brain and Spine Center
Annapolis, Maryland, 21401
Illinois Neuro-Spine Center
Aurora, Illinois, 60504
Tower Orthopedics and Sports Medicine
Beverly Hills, California, 90211
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, 27704
CORE Orthopaedic Medical Center
Encinitas, California, 92024
Hamilton Orthopaedic Surgery and Sports Medicine
Hamilton, New York, 13346
Orthopedics International Spine
Kirkland, Washington, 98034
Buffalo Spine Surgery
Lockport, New York, 14094
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, 80538
Manhattan Orthopaedics, P.C.
New York, New York, 10021
Kaiser Oakland Regional Spine Surgery
Oakland, California, 94611
Univ. of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Texas Back Institute Clinical Research Organization
Plano, Texas, 75093
Sierra Regional Spine Institute
Reno, Nevada, 89509
Loma Linda University
San Bernardino, California, 92408
University of California San Diego
San Diego, California, 92103
UCSF Dept. of Orthopaedic Surgery
San Francisco, California, 94122
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Orthopaedic Associates, P.A
Towson, Maryland, 21204
Gordon Spine Associates
Tyler, Texas, 75701
About this study
Official title: Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage
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.
Read the 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- Lumbar Artificial Disc, Charite Artificial Disc
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Artificial DiscDevice
Also called Kineflex Disc
Insertion of the Kineflex Lumbar ArtificialDisc
Charite Artificial DiscDevice
Also called SB Charite
Insertion of the Charite
| Study group | Role | What they receive |
|---|---|---|
| Kineflex Lumbar Artificial Disc | Experimental | Treatment arm Receives: Device: Lumbar Artificial Disc |
| Charite | Active comparator | Not described Receives: Device: Charite Artificial Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (7)
Maintenance or improvement in neurologic status
Measured: 24 months
Pain improvement
Measured: 24 months
Significant disc height increase
Measured: 24 months
No displacement or migration of the device
Measured: 24 months
Time to return to work
Measured: 24 months
Time to recovery
Measured: 24 months
Preservation of at least 4 degrees of motion in flexion/extension
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJan 2005
- Primary completionMay 2009
- Study completionAug 2013
Why it stopped: Economic and business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpinalMotion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Geisler, MD, Principal investigator, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292292
- Sponsor's protocol ID
- Kineflex
- Status last verified
- Aug 2013
- First submitted
- 13 Feb 2006
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage
- ClinicalTrials.gov ID
- NCT00292292
- Acronym / sponsor ID
- Kineflex
- Conditions
- Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Economic and business reasons
- Enrolment
- 514 participants (actual)
- Lead sponsor
- SpinalMotionIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kineflex Lumbar Artificial Disc | Experimental | Device: Lumbar Artificial DiscTreatment arm |
| Charite | Active comparator | Device: Charite Artificial Disc |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Artificial DiscAlso: Kineflex DiscInsertion of the Kineflex Lumbar ArtificialDisc | Device | Kineflex Lumbar Artificial Disc |
| Charite Artificial DiscAlso: SB ChariteInsertion of the Charite | Device | Charite |
Primary outcome
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
7 secondary outcomes
Maintenance or improvement in neurologic status
Time frame: 24 months
Pain improvement
Time frame: 24 months
Significant disc height increase
Time frame: 24 months
No displacement or migration of the device
Time frame: 24 months
Time to return to work
Time frame: 24 months
Time to recovery
Time frame: 24 months
Preservation of at least 4 degrees of motion in flexion/extension
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Economic and business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- sponsors web site contains animated information regarding discLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Geisler, MD principal investigator
Medical Monitor
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Artificial Disc and Charite Artificial Disc in people with Degenerative Disc Disease, run by SpinalMotion at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Economic and business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013.