Cervical Intervertebral Disc DegenerationNCT01832818
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
A study testing NuNec Cervical Disc in people with Cervical Intervertebral Disc Degeneration, run by Pioneer Surgical Technology, Inc. at 1 site in United Kingdom.
Trial summary
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cervical Intervertebral Disc Degeneration
- What is being tested?
- NuNec Cervical Disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is at least 21 years of age and skeletally mature
- must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis;
- must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment
- must score at least 15/50 (30%) on the Neck Disability Index
- is willing and able to follow the post-operative management program
- must understand and sign the informed consent document
Who cannot join
- symptomatic cervical DDD at more than one level
- axial neck pain as the primary diagnosis without evidence of neural compression
- neck or arm pain of unknown etiology
- any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible
- severe spondylosis at the target level
- prior surgery at the target level
Show all 19Show fewer
- fused level adjacent to the target level
- osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease
- active infection or surgical site infection
- is using any medication known to interfere with bone/soft tissue healing
- diabetes mellitus requiring daily insulin management
- any terminal, systemic, or autoimmune disease
- medical conditions or mental incompetence which may interfere with study requirements
- BMI >40 or a weight more than 100 lbs over ideal body weight
- chemical dependency problem that may interfere with study requirements
- current smokers
- history of any invasive malignancy unless treated and in remission for at least two years
- documented allergies to metal or plastic
- currently pregnant, or interested in becoming pregnant during the study follow-up
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of North Tees
Stockton-on-Tees
About this study
Official title: A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
Read the detailed description
The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled.
Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.
- Being tested
- NuNec Cervical Disc
- Keywords
- Total Disc Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuNec Cervical DiscDevice
Also called NuNec Cervical Arthroplasty System
Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
| Study group | Role | What they receive |
|---|---|---|
| NuNec Cervical Disc | Experimental | Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. Receives: Device: NuNec Cervical Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI) Score Improvement of at Least 15 Points
The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.
Measured: At 24 months
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). A higher score would indicate that the patient had a worse outcome.
Measured: At 24 months
Serious Adverse Events Related to the Device
The number of serious adverse events have been recorded
Measured: Up to 24 months
Device Failures or Removals, Revisions, Re-operations
The failures or re-operations or supplemental fixation at the treated level
Measured: Up to 24 months
Secondary outcomes (2)
Patient Satisfaction
As assessed on patient questionnaire.
Measured: At 24 months
Absence of Device Migration or Subsidence
Absence of device migration > 3mm; Absence of device subsidence > 3mm
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startMar 2012
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: This study has been terminated early due to slow enrolment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Intervertebral Disc DegenerationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pioneer Surgical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tai Friesem, MD, Principal investigator, University Hospital of North Tees
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832818
- Sponsor's protocol ID
- C01
- Status last verified
- Oct 2018
- First submitted
- 10 Apr 2013
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
- ClinicalTrials.gov ID
- NCT01832818
- Acronym / sponsor ID
- C01
- Keywords
- Total Disc Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated early due to slow enrolment.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pioneer Surgical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
Detailed description
The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled.
Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NuNec Cervical Disc | Experimental | Device: NuNec Cervical DiscEach patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- is at least 21 years of age and skeletally mature
- must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis;
- must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment
- must score at least 15/50 (30%) on the Neck Disability Index
- is willing and able to follow the post-operative management program
Key exclusion criteria (19 listed)
- symptomatic cervical DDD at more than one level
- axial neck pain as the primary diagnosis without evidence of neural compression
- neck or arm pain of unknown etiology
- any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible
- severe spondylosis at the target level
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 |
|---|---|---|
| NuNec Cervical DiscAlso: NuNec Cervical Arthroplasty SystemPatients will be enrolled and implanted with the NuNec device at a single level C3 to C7. | Device | NuNec Cervical Disc |
Primary outcome
Neck Disability Index (NDI) Score Improvement of at Least 15 Points
Time frame: At 24 months
The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
Time frame: At 24 months
The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). A higher score would indicate that the patient had a worse outcome.
Serious Adverse Events Related to the Device
Time frame: Up to 24 months
The number of serious adverse events have been recorded
Device Failures or Removals, Revisions, Re-operations
Time frame: Up to 24 months
The failures or re-operations or supplemental fixation at the treated level
2 secondary outcomes
Patient Satisfaction
Time frame: At 24 months
Absence of Device Migration or Subsidence
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Tai Friesem, MD principal investigator
University Hospital of North Tees
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuNec Cervical Disc in people with Cervical Intervertebral Disc Degeneration, run by Pioneer Surgical Technology, Inc. at 1 site in United Kingdom.
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 6 inclusion and 19 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neck Disability Index (NDI) Score Improvement of at Least 15 Points (time frame: At 24 months). The study lists 4 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 15 Feb 2019.