Cervical RadiculopathyNCT01609374
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A study testing M6-C Artificial Cervical Disc and Anterior plate system with corticocancellous allograft bone in people with Cervical Radiculopathy and Degenerative Disc Disease, run by Spinal Kinetics.
Trial summary
This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Radiculopathy, Degenerative Disc Disease
- What is being tested?
- M6-C Artificial Cervical Disc and Anterior plate system with corticocancellous allograft bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- May 2014to 31 Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at one level from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
- Inadequate response to conservative medical care over a period of at least 6 weeks
- Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
- Neck or arm pain VAS ≥ 4 on a scale of 0 to 10
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent
- Skeletally mature and ≥ 18 years old and ≤ 75 years old
Who cannot join
- More than one cervical level requiring surgery
- Previous anterior cervical spine surgery
- Axial neck pain as the solitary symptom
- Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine
- Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels
- Symptomatic facet arthrosis
Show all 26Show fewer
- Less than 4º of motion in flexion/extension at the index level
- Instability as evidenced by subluxation > 3 mm at the index or adjacent levels as indicated on flexion/extension x-rays
- Advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by bridging osteophytes, central disc height < 4mm and/or < 50% of the adjacent normal intervertebral disc, or kyphotic deformity > 11º on neutral x-rays
- Severe cervical myelopathy (i.e., Nurick's Classification > 2)
- Active systemic infection or infection at the operative site
- Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
- Metabolic bone disease such as osteoporosis that contradicts spinal surgery (for females over 50 and males over 55 years old, or if the score on the Osteoporosis Self-Assessment Test is < 2, a dual energy x-ray absorptiometry [DEXA scan] of the spine is required; if the bone mineral density T-score in the spine is ≤ -2.5 the patient must be excluded)
- History of an osteoporotic fracture of the spine, hip or wrist
- History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
- Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
- Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
- Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
- Insulin-dependent type 1 or type 2 diabetes
- Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
- Pregnant, or intend to become pregnant, during the course of the study
- Severe obesity (Body Mass Index > 40)
- Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
- Involved in current or pending spinal litigation where permanent disability benefits are being sought
- Incarcerated at the time of study enrollment
- Current participation in other investigational study that may impact study outcomes
About this study
Official title: Prospective, Non-Randomized, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics™ M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Radiculopathy
This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients.
Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7.
A total of 243 subjects will be included at up to 20 sites.
- Conditions
- Cervical Radiculopathy, Degenerative Disc Disease
- Being tested
- M6-C Artificial Cervical Disc, Anterior plate system with corticocancellous allograft bone
- Keywords
- Spinal Kinetics, artificial cervical disc, cervical radiculopathy, ACDF, neck pain, cervical spine, degenerative disc disease
- Medical subject headings
- Radiculopathy, Intervertebral Disc Degeneration, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M6-C Artificial Cervical DiscDevice
Total disc replacement
Anterior plate system with corticocancellous allograft boneDevice
Cervical fusion
| Study group | Role | What they receive |
|---|---|---|
| M6-C Artificial Cervical Disc | Experimental | Not described Receives: Device: M6-C Artificial Cervical Disc |
| Anterior Cervical Discectomy and Fusion | Active comparator | Not described Receives: Device: Anterior plate system with corticocancellous allograft bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation through 24 months
Evaluate the safety by assessing adverse events and neurological function following implantation with the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)
Measured: 24 months
Effectiveness Evaluation through 24 months
Evaluate the effectiveness using Neck Disability Index (NDI)
Measured: 24 months
Secondary outcomes (1)
Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)
Evaluate the Neck and Arm pain VAS, health-related quality of life SF-36, surgery outcomes, patient satisfaction and quantitative and qualitative radiographic assessments
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startMay 2014
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized, concurrent ACDF control
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Kinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609374
- Sponsor's protocol ID
- CA-C002
- Status last verified
- Mar 2019
- First submitted
- 24 May 2012
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics™ M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT01609374
- Acronym / sponsor ID
- CA-C002
- Conditions
- Cervical Radiculopathy, Degenerative Disc Disease
- Keywords
- Spinal Kinetics, artificial cervical disc, cervical radiculopathy, ACDF, neck pain, cervical spine, degenerative disc disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Spinal KineticsIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 Jun 2012 (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.
This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients.
Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7.
A total of 243 subjects will be included at up to 20 sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomized, concurrent ACDF control
| Arm | Type | Receives |
|---|---|---|
| M6-C Artificial Cervical Disc | Experimental | Device: M6-C Artificial Cervical Disc |
| Anterior Cervical Discectomy and Fusion | Active comparator | Device: Anterior plate system with corticocancellous allograft bone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at one level from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
- Inadequate response to conservative medical care over a period of at least 6 weeks
- Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
- Neck or arm pain VAS ≥ 4 on a scale of 0 to 10
- Willing and able to comply with the requirements of the protocol including follow-up requirements
Key exclusion criteria (26 listed)
- More than one cervical level requiring surgery
- Previous anterior cervical spine surgery
- Axial neck pain as the solitary symptom
- Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine
- Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels
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 |
|---|---|---|
| M6-C Artificial Cervical DiscTotal disc replacement | Device | M6-C Artificial Cervical Disc |
| Anterior plate system with corticocancellous allograft boneCervical fusion | Device | Anterior Cervical Discectomy and Fusion |
Primary outcome
Safety Evaluation through 24 months
Time frame: 24 months
Evaluate the safety by assessing adverse events and neurological function following implantation with the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)
Effectiveness Evaluation through 24 months
Time frame: 24 months
Evaluate the effectiveness using Neck Disability Index (NDI)
1 secondary outcome
Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing M6-C Artificial Cervical Disc and Anterior plate system with corticocancellous allograft bone in people with Cervical Radiculopathy and Degenerative Disc Disease, run by Spinal Kinetics.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Safety Evaluation through 24 months (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?
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 18 Sep 2019.