Cervical Intervertebral Disc DegenerationPhase 3NCT00215293
Cervical I/F Cage for Anterior Cervical Fusion
A Phase 3 study testing Cervical I/F Cage and Autograft or allograft with a plate, or autograft alone. in people with Cervical Intervertebral Disc Degeneration, run by DePuy Spine.
Trial summary
The purpose of this study is to determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Intervertebral Disc Degeneration
- What is being tested?
- Cervical I/F Cage and Autograft or allograft with a plate, or autograft alone.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Oct 2007
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent recurrent neck and/or shoulder and arm pain refractory to 6 weeks of non-surgical therapy.
- Radiographic evidence of significant disc degeneration at one or two adjacent cervical levels (C4-7)
Who cannot join
- Significant degeneration at more than two cervical levels,
- Prior surgical treatment of the cervical spine; laminotomy or foraminotomy allowed,
- Gross instability due to trauma,
- Disability in the lumbar spine,
- Infection in the disc or spine, past or present,
- Any active infection at time of surgery,
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- Tumor in the spine,
- Significant osteoporosis or metabolic bone disease,
- Pregnant, lactating or wishes to become pregnant within duration of the study,
- Refusal to accept the use of autograft tissue.
About this study
Official title: A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion
The purpose of this study is to determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate
Read the detailed description
This is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent levels of the cervical spine. Patients will be randomly assigned in a ration of 1:1 between the investigational and control groups.
Comparison: The device will be compared to a control group consisting of the 3 accepted standard of care treatments (autograft, autograft with an anterior plate, or allograft with an anterior plate). For two level fusions, the control group will be limited to autograft with a plate or allograft with a plate. Based on the current literature, it is believed that there is no difference between the three treatments in terms of clinical success, fusion success, or safety issues. However, amongst the investigators there are preferred treatments. Each investigator will choose one or more of the control treatments at study initiation. Patients will then be randomized in a 1:1 Cage:control randomization schema. Approximately 240 subjects will be enrolled at 20 sites. Eligible patients will have symptomatic degeneration of one or two adjacent cervical discs, have failed six weeks of non-surgical treatment, have sufficiently severe enough symptoms to warrant surgery, and have had no prior fusion surgery on the cervical spine.
- Being tested
- Cervical I/F Cage, Autograft or allograft with a plate, or autograft alone.
- Keywords
- fusion, cervical, spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical I/F CageDevice
Autograft or allograft with a plate, or autograft alone.Device
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cage | Experimental | Cervical I/F Cage Receives: Device: Cervical I/F Cage |
| Graft Spacer | Active comparator | Autograft or allograft with a plate, or autograft alone. Receives: Device: Autograft or allograft with a plate, or autograft alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Status
Measured: 24 months
Neck Disability Index
Neurological Status
Secondary Surgical Interventions
Secondary outcomes (7)
Adverse Events
Donor Site Pain
Neck Pain
Arm Pain
Disc Space Height
Sagittal Alignment
SF-36, Health Related Quality of Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2000
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215293
- Sponsor's protocol ID
- G000019
- Status last verified
- May 2014
- First submitted
- 13 Sep 2005
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion
- ClinicalTrials.gov ID
- NCT00215293
- Acronym / sponsor ID
- G000019
- Keywords
- fusion, cervical, spine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- DePuy SpineIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Sep 2005 (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 determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate
Detailed description
This is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent levels of the cervical spine. Patients will be randomly assigned in a ration of 1:1 between the investigational and control groups.
Comparison: The device will be compared to a control group consisting of the 3 accepted standard of care treatments (autograft, autograft with an anterior plate, or allograft with an anterior plate). For two level fusions, the control group will be limited to autograft with a plate or allograft with a plate. Based on the current literature, it is believed that there is no difference between the three treatments in terms of clinical success, fusion success, or safety issues. However, amongst the investigators there are preferred treatments. Each investigator will choose one or more of the control treatments at study initiation. Patients will then be randomized in a 1:1 Cage:control randomization schema. Approximately 240 subjects will be enrolled at 20 sites. Eligible patients will have symptomatic degeneration of one or two adjacent cervical discs, have failed six weeks of non-surgical treatment, have sufficiently severe enough symptoms to warrant surgery, and have had no prior fusion surgery on the cervical spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Cage | Experimental | Device: Cervical I/F CageCervical I/F Cage |
| Graft Spacer | Active comparator | Device: Autograft or allograft with a plate, or autograft alone.Autograft or allograft with a plate, or autograft alone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persistent recurrent neck and/or shoulder and arm pain refractory to 6 weeks of non-surgical therapy.
- Radiographic evidence of significant disc degeneration at one or two adjacent cervical levels (C4-7)
Key exclusion criteria (10 listed)
- Significant degeneration at more than two cervical levels,
- Prior surgical treatment of the cervical spine; laminotomy or foraminotomy allowed,
- Gross instability due to trauma,
- Disability in the lumbar spine,
- Infection in the disc or spine, past or present,
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 |
|---|---|---|
| Cervical I/F Cage | Device | Cervical Cage |
| Autograft or allograft with a plate, or autograft alone. | Device | Graft Spacer |
Primary outcome
Fusion Status
Time frame: 24 months
Neck Disability Index
Neurological Status
Secondary Surgical Interventions
7 secondary outcomes
Adverse Events
Donor Site Pain
Neck Pain
Arm Pain
Disc Space Height
Sagittal Alignment
SF-36, Health Related Quality of Life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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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 Phase 3 study testing Cervical I/F Cage and Autograft or allograft with a plate, or autograft alone. in people with Cervical Intervertebral Disc Degeneration, run by DePuy Spine.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 23 May 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fusion Status (time frame: 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 23 May 2014.