Degenerative Disc Disease (DDD)NCT00374413
Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)
A study testing Artificial disk and Artificial disc in people with Degenerative Disc Disease (DDD), run by SpinalMotion at 21 sites in United States.
Trial summary
The purpose of this study is to show that the Kineflex|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Degenerative Disc Disease (DDD)
- What is being tested?
- Artificial disk and Artificial disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 21 sitesUnited States
- Study dates
- Jul 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
- have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI;
- have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms;
- have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression;
- have moderate disability neck disability index (NDI) score; AND
- be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation
Who cannot join
- marked cervical instability;
- non discogenic neck pain or non discogenic source of symptoms;
- radiographic confirmation of severe facet disease or facet degeneration;
- bridging osteophytes;
- prior surgery at the level to be treated;
- prior fusion at any cervical level;
Show all 26Show fewer
- more than one neck surgery via anterior approach;
- previous trauma to the C3-C7 levels resulting in compression or bursting;
- documented presence of free nuclear fragment at any cervical level;
- severe myelopathy;
- any paralysis;
- history of chemical or alcohol dependence;
- active systemic infection;
- infection at the site of surgery;
- prior disc space infection or osteomyelitis in the cervical spine;
- any terminal, systemic or autoimmune disease;
- metabolic bone disease (e.g., osteoporosis, gout, osteomalacia, Paget's disease);
- any disease, condition or surgery which might impair healing;
- known metal allergy;
- arachnoiditis;
- currently experiencing an episode of major mental illness;
- pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery;
- morbid obesity; use of spinal stimulator at any cervical level prior to surgery;
- currently a prisoner;
- currently involved in spinal litigation which may influence the subjects reporting of symptoms; OR
- lives more than 300 miles from study center or participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery
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
Emory Orthopaedics & Spine Center
Atlanta, Georgia, 30329
Tower Orthopedics and Sports Medicine
Beverly Hills, California, 90211
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28207
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, 27704
Hamilton Orthopaedic Surgery and Sports Medicine
Hamilton, New York, 13346
Orthopedics International Spine
Kirkland, Washington, 98034
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, 80538
Semmes-Murphy Clinic
Memphis, Tennessee, 38104
Northern Westchester Hospital
Mount Kisco, New York, 10549
Manhattan Orthopaedics, P.C.
New York, New York, 10021
Kaiser Foundation Research Institute
Oakland, California, 94612
Univ. of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Plano Orthopedic Sports Medicine & Spine Center
Plano, Texas, 75093
SpineMark CRO at Texas Back Institue
Plano, Texas, 75093
Sierra Regional Spine Institute
Reno, Nevada, 89509
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California San Diego
San Diego, California, 92103
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|C Spinal System - a Pivotal Study in Continued Access Stage
The purpose of this study is to show that the Kineflex|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.
Read the detailed description
The Kineflex|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two foot print sizes.
- Conditions
- Degenerative Disc Disease (DDD)
- Being tested
- Artificial disk, Artificial disc
- Keywords
- DDD, 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.
Artificial diskDevice
Implant
Artificial discDevice
Implant
| Study group | Role | What they receive |
|---|---|---|
| Kineflex-C | Experimental | Not described Receives: Device: Artificial disk; Device: Artificial disc |
| ACDF | Active comparator | Not described Receives: Device: Artificial disk; Device: Artificial disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline
Measured: 24 months
No major device related adverse events
Measured: 24 months
Secondary outcomes (7)
Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline
Measured: 24 months
Time to recovery
Measured: 24 months
Disc height at 24 months compared to baseline
Measured: 24 months
Adjacent level deterioration at 24 months compared to baseline
Measured: 24 months
Progressive facet disease at 24 months compared to baseline
Measured: 24months
Displacement or migration of the device
Measured: 24 months
Odom's Criteria
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 posted11 Sep 2006 (estimated)
- Study startJul 2005
- Primary completionJan 2010
- Study completionAug 2013
Why it stopped: Economic and business factors
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc Disease (DDD)Studies 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
- 343 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
- NCT00374413
- Sponsor's protocol ID
- Kineflex|C
- Status last verified
- Aug 2013
- First submitted
- 7 Sep 2006
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Coric D, Guyer RD, Nunley PD, Musante D, Carmody C, Gordon C, Lauryssen C, Boltes MO, Ohnmeiss DD. Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc. J Neurosurg Spine. 2018 Mar;28(3):252-261. doi: 10.3171/2017.5.SPINE16824. Epub 2018 Jan 5.
PubMed 29303467Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24.
PubMed 21699471
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|C Spinal System - a Pivotal Study in Continued Access Stage
- ClinicalTrials.gov ID
- NCT00374413
- Acronym / sponsor ID
- Kineflex|C
- Conditions
- Degenerative Disc Disease (DDD)
- Keywords
- DDD, artificial disc
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Economic and business factors
- Enrolment
- 343 participants (actual)
- Lead sponsor
- SpinalMotionIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Sep 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 purpose of this study is to show that the Kineflex|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.
Detailed description
The Kineflex|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two 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-C | Experimental | Device: Artificial disk, Device: Artificial disc |
| ACDF | Active comparator | Device: Artificial disk, Device: Artificial disc |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI;
- have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms;
- have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression;
- have moderate disability neck disability index (NDI) score; AND
- be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation
Key exclusion criteria (26 listed)
- marked cervical instability;
- non discogenic neck pain or non discogenic source of symptoms;
- radiographic confirmation of severe facet disease or facet degeneration;
- bridging osteophytes;
- prior surgery at the level to be treated;
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 |
|---|---|---|
| Artificial diskImplant | Device | ACDF, Kineflex-C |
| Artificial discImplant | Device | ACDF, Kineflex-C |
Primary outcome
Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline
Time frame: 24 months
No major device related adverse events
Time frame: 24 months
7 secondary outcomes
Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline
Time frame: 24 months
Time to recovery
Time frame: 24 months
Disc height at 24 months compared to baseline
Time frame: 24 months
Adjacent level deterioration at 24 months compared to baseline
Time frame: 24 months
Progressive facet disease at 24 months compared to baseline
Time frame: 24months
Displacement or migration of the device
Time frame: 24 months
Odom's Criteria
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Economic and business factors). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- Derived from this study: PubMed 29303467Coric D, Guyer RD, Nunley PD, Musante D, Carmody C, Gordon C, Lauryssen C, Boltes MO, Ohnmeiss DD. Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc. J Neurosurg Spine. 2018 Mar;28(3):252-261. doi: 10.3171/2017.5.SPINE16824. Epub 2018 Jan 5.
- Derived from this study: PubMed 21699471Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24.
- Related InfoLink 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 Artificial disk and Artificial disc in people with Degenerative Disc Disease (DDD), 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 5 inclusion and 26 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 factors). 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 Neck Disability Index (NDI) Score at 24 months compared with baseline (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374413, which also lists 2 linked publications.
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.