Radiating PainCASCADENCT01511445
Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome
A study testing Anterior cervical discectomy and fusion (ACDF) with PEEK Cage and Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage in people with Radiating Pain and Myelopathy, run by Amedica Corporation at 1 site in Netherlands.
Trial summary
This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiating Pain, Myelopathy, Cervicobrachial Syndrome
- What is being tested?
- Anterior cervical discectomy and fusion (ACDF) with PEEK Cage and Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2011to Nov 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 75 years
- Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
- At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication)
- Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms
- Ability and willingness to comply with project requirements
- Written informed consent given by the subject or the subject's legally authorised representative
Who cannot join
- Previous cervical surgery (either anterior or posterior)
- Increased motion on dynamic studies (> 3 mm)
- Severe segmental kyphosis of the involved disc level (> 7 degrees)
- Patient cannot be imaged with MRI
- Neck pain only (without radicular or medullary symptoms)
- Infection
Show all 12Show fewer
- Metabolic and bone diseases (osteoporosis, severe osteopenia)
- Neoplasma or trauma of the cervical spine
- Spinal anomaly (Klippel Feil, Bechterew, OPLL)
- Severe mental or psychiatric disorder
- Inadequate Dutch language
- Planned (e)migration abroad in the year after inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.
This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
- Conditions
- Radiating Pain, Myelopathy, Cervicobrachial Syndrome
- Being tested
- Anterior cervical discectomy and fusion (ACDF) with PEEK Cage, Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
- Keywords
- Cervicobrachial pain, radicular pain, arm pain, myelopathy, radiculitis, Radiating pain with or without signs of myelopathy.
- Medical subject headings
- Pain, Spinal Cord Diseases, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cervical discectomy and fusion (ACDF) with PEEK CageDevice
Also called Medicrea Manta or similar PEEK cage
Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC CageDevice
Also called Valeo CSC (Cancellous Structured Ceramic), Silicon Nitride ceramic
Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.
| Study group | Role | What they receive |
|---|---|---|
| ACDF with PEEK interbody cage | Active comparator | Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure. Receives: Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage |
| ACDF with Valeo CSC Ceramic Cage | Experimental | ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood. Receives: Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.
Measured: 24 months post-op
Secondary outcomes (1)
Fusion Status
Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.
Measured: 3 mo., 6mo., 12 mo., 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2014
- Study completionNov 2015
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 Radiating PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amedica Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark P Arts, MD, PhD, Principal investigator, Medical Center Haaglanden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511445
- Sponsor's protocol ID
- Amedica 2010-1
- Other IDs
- NL36103.098.11
- Acronym
- CASCADE
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2012
- Last updated
- 8 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.
- ClinicalTrials.gov ID
- NCT01511445
- Acronym / sponsor ID
- CASCADE / Amedica 2010-1
- Conditions
- Radiating Pain, Myelopathy, Cervicobrachial Syndrome
- Keywords
- Cervicobrachial pain, radicular pain, arm pain, myelopathy, radiculitis, Radiating pain with or without signs of myelopathy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amedica CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Posted 8 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACDF with PEEK interbody cage | Active comparator | Device: Anterior cervical discectomy and fusion (ACDF) with PEEK CageAnterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure. |
| ACDF with Valeo CSC Ceramic Cage | Experimental | Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC CageACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 75 years
- Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
- At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication)
- Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms
- Ability and willingness to comply with project requirements
Key exclusion criteria (12 listed)
- Previous cervical surgery (either anterior or posterior)
- Increased motion on dynamic studies (> 3 mm)
- Severe segmental kyphosis of the involved disc level (> 7 degrees)
- Patient cannot be imaged with MRI
- Neck pain only (without radicular or medullary symptoms)
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 |
|---|---|---|
| Anterior cervical discectomy and fusion (ACDF) with PEEK CageAlso: Medicrea Manta or similar PEEK cageAnterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer | Device | ACDF with PEEK interbody cage |
| Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC CageAlso: Valeo CSC (Cancellous Structured Ceramic), Silicon Nitride ceramicAnterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer. | Device | ACDF with Valeo CSC Ceramic Cage |
Primary outcome
Neck Disability Index
Time frame: 24 months post-op
The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.
1 secondary outcome
Fusion Status
Time frame: 3 mo., 6mo., 12 mo., 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mark P Arts, MD, PhD principal investigator
Medical Center Haaglanden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cervical discectomy and fusion (ACDF) with PEEK Cage and Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage in people with Radiating Pain and Myelopathy, run by Amedica Corporation at 1 site in Netherlands.
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 12 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 8 May 2017. 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 Netherlands. 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 8 May 2017). 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 (time frame: 24 months post-op). 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 8 May 2017.