Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7NCT01763619
Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
A study testing Freedom Cervical Disc in people with Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7, run by AxioMed Spine Corporation at 5 sites in 2 countries.
Trial summary
This study will collect clinical and radiographic data on the Freedom Cervical Disc to monitor the device's safety and performance as part of a post-market evaluation. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7
- What is being tested?
- Freedom Cervical Disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Feb 2013to Jul 2017
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature males or females, aged 21 to 65 years old, inclusive.
- Single, or adjacent, 2-level degenerative disc disease at C3-C7, inclusive.
- Subject is a surgical candidate for an anterior approach to the cervical spine.
- Minimum of 6 weeks of unsuccessful conservative treatment.
- Subject with at least moderate preoperative pain and functional impairment
- Subject is mentally and physically able to comply with protocol, postoperative compliance instructions, and follow-up schedule through 2-years.
- Subject must understand and sign the written Informed Consent form.
Who cannot join
- Subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm).
- An active infection at the operative site or active systemic infection at the time of surgery.
- Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
- Previous spinal fusion at the involved, or adjacent, cervical level(s).
- Congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s).
- Significant osteoporosis in the cervical spine.
Show all 13Show fewer
- The investigator should assess if the subject has any of the following conditions at the index or adjacent level(s) which excludes the subject from study participation:
- Cervical facet degeneration of the involved C3-C7 levels.
- Previous trauma to, or fusion in, the C3-C7 levels.
- Cervical instability at the index level(s) on neutral lateral or flexion/extension x-rays.
- Radiographic findings of a fused or total collapsed disc.
- Significant global cervical kyphosis (≥15º on Cobb angle measurement) or significant reversal of lordosis.
- Female of childbearing potential, pregnant, breast feeding, or interested in becoming pregnant in the next two years
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Universitatsklinikum Bonn
Bonn, 53105
Stadtisches Klinikum Gorlitz
Görlitz, 02828
Stadtisches Klinikum Karlsruhe
Karlsruhe, 76133
Switzerland2 sites
Klinik St. Anna
Lucerne, CH-6006
Spine Center Rischke
Zurich, CH 8001
About this study
This study will collect clinical and radiographic data on the Freedom Cervical Disc to monitor the device's safety and performance as part of a post-market evaluation.
- Being tested
- Freedom Cervical Disc
- Keywords
- Cervical DDD, DDD, degenerative disc disease, C3-C7
- Medical subject headings
- Dowling-Degos Disease, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom Cervical DiscDevice
| Study group | Role | What they receive |
|---|---|---|
| Freedom Cervical Disc | Experimental | Not described Receives: Device: Freedom Cervical Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of FCD
Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD.
Measured: 6 months
Performance of FCD
Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.
Measured: 6 months
Secondary outcomes (6)
Incidence of AEs
Examine the incidence of adverse events including device revision, removal or supplemental fixation through the 2-years post-operative period.
Measured: 2 year
Neck/Arm Pain
Examine changes in neck and arm pain throughout the 2-years post-operative period.
Measured: 2 years
Neurological function
Examine changes in subject neurological function throughout the 2-years post-operative period.
Measured: 2 years
Subject Function
Examine changes in subject function throughout the 2-years post-operative period.
Measured: 2 years
Radiographic Measurements
Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years.
Measured: 2 years
Examine AEs
Examine all adverse events throughout the 2-years post-operative period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7Studies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AxioMed Spine Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763619
- Sponsor's protocol ID
- PR-300
- Status last verified
- Jul 2016
- First submitted
- 4 Jan 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT01763619
- Acronym / sponsor ID
- PR-300
- Keywords
- Cervical DDD, DDD, degenerative disc disease, C3-C7
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AxioMed Spine CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 9 Jan 2013 (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 study will collect clinical and radiographic data on the Freedom Cervical Disc to monitor the device's safety and performance as part of a post-market evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freedom Cervical Disc | Experimental | Device: Freedom Cervical Disc |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Skeletally mature males or females, aged 21 to 65 years old, inclusive.
- Single, or adjacent, 2-level degenerative disc disease at C3-C7, inclusive.
- Subject is a surgical candidate for an anterior approach to the cervical spine.
- Minimum of 6 weeks of unsuccessful conservative treatment.
- Subject with at least moderate preoperative pain and functional impairment
Key exclusion criteria (13 listed)
- Subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm).
- An active infection at the operative site or active systemic infection at the time of surgery.
- Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
- Previous spinal fusion at the involved, or adjacent, cervical level(s).
- Congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s).
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 |
|---|---|---|
| Freedom Cervical Disc | Device | Freedom Cervical Disc |
Primary outcome
Safety of FCD
Time frame: 6 months
Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD.
Performance of FCD
Time frame: 6 months
Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.
6 secondary outcomes
Incidence of AEs
Time frame: 2 year
Neck/Arm Pain
Time frame: 2 years
Neurological function
Time frame: 2 years
Subject Function
Time frame: 2 years
Radiographic Measurements
Time frame: 2 years
Examine AEs
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freedom Cervical Disc in people with Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7, run by AxioMed Spine Corporation at 5 sites in 2 countries.
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 13 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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Switzerland. 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?
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 of FCD (time frame: 6 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 29 Jul 2016.