Cervical Spine Disc DiseaseNCT03187171
ACDF Comparison Trial
A study testing Allograft Fusion and Cohere PEEK Fusion Group in people with Cervical Spine Disc Disease and Surgery, run by Duke University.
Trial summary
This research protocol seeks to compare radiological and clinical outcomes of cervical spine disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF) using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cervical Spine Disc Disease, Surgery, Fusion of Spine
- What is being tested?
- Allograft Fusion and Cohere PEEK Fusion Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 23 Apr 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or more years of age
- Able to provide informed consent
- Has documented diagnosis of cervical spine radiculopathy and/or myelopathy
- Is undergoing standard-of-care ACDF
Who cannot join
- Prior cervical spine surgery
- Single-level ACDF
- Has a systemic infection or cervical spine infection
- Has a medical condition that may interfere with bone and soft tissue healing
- Any condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.
About this study
Official title: Comparison of Outcomes After ACDF Using Allograft Fusion Versus PEEK Fusion: a Prospective Clinical Trial
This research protocol seeks to compare radiological and clinical outcomes of cervical spine disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF) using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device.
This clinical study presents little to no additional risk to study subjects beyond those associated with standard-of-care ACDF surgery. Adults age 18 and over who are undergoing an ACDF procedure will be enrolled in the study. The study consists of a completing a series of questionnaires and obtaining radiographs. The primary endpoint of the study will be the rate of successful spinal fusion for each group. For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to the device used and/or procedures performed.
Read the detailed description
This is a prospective randomized comparative outcomes study, in which all subjects who fit the inclusion and exclusion criteria and who agreed to be part of the study will be randomized to either Allograft or Cohere polyetheretherketone (PEEK) fusion group and will be followed for approximately 12 months following surgery according to the standard-of-care.
Pain and function will be assessed using neck disability index (NDI), 36-Item Short Form Survey (SF-36), and Numeric Rating Scale (NRS). A trained study team member will record a standardized neurologic examination, including motor, sensory, and reflexes. Neurologic success is defined as maintenance or improvement of all 3 neurologic parameters (motor, sensory, and reflexes). The clinical results will also be assessed using the Japanese Orthopedic Association (JOA) scoring system for cervical myelopathy.
Flexion and extension radiographs will be obtained pre-operatively, at 6-months and 12-months after surgery. A CT scan will be obtained at 6 months, if fusion has occurred no CT is needed at 12 months, if fusion did not occur another computerized tomography (CT) scan will obtained at 12 months. From previous literature, successful fusion is defined as ≤2° of angular motion on lateral flexion and extension radiographs, the presence of bridging trabecular bone between the vertebrae being fused, and the absence of any radiolucent zones spanning more than 50% of the allograft surface. Two independent blinded radiologists will assess the radiographs. In the event of disagreement about fusion healing, a third independent reading will be obtained from a third radiologist.
- Being tested
- Allograft Fusion, Cohere PEEK Fusion Group
- Keywords
- Anterior Cervical Spine Fusion
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allograft FusionOther
ACDF is a surgical technique used to treat a variety of cervical spine disorders, such as nerve root or spinal cord compression, cervical spondylosis, and cervical spinal stenosis. The anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft was first described by Robinson and Smith in 1955. In 1958, Cloward described a wide anterior cylindrical discectomy performed with a special reamer combined with anterior fusion by the insertion of autologous iliac bone graft of the same shape. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF.
Cohere PEEK Fusion GroupDevice
Also called Fusion Device, PEEK Cage
Bagby et al. developed the first interbody fusion cage. Cages of different shapes and materials are used to perform ACDF which, in some cases, could be associated with plate fixation. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF.
| Study group | Role | What they receive |
|---|---|---|
| Allograft Fusion Group | Active comparator | The anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft. Receives: Other: Allograft Fusion |
| Cohere PEEK Fusion Group | Active comparator | The anterior approach to the cervical spine for discectomy and fusion by the insertion of a Cohere porous PEEK fusion device. Receives: Device: Cohere PEEK Fusion Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful fusion.
To compare post-operative bone fusion following standard-of-care ACDF using allograft fusion or Cohere porous PEEK fusion.
Measured: 18 months
Secondary outcomes (1)
Overall success rate - composite score.
To be considered an overall success, patients have to achieve all of the following: a ≥15 point improvement in their NDI scores, maintenance or improvement in their neurologic status, no serious adverse events related to the implant or surgical procedure, and no subsequent surgery or intervention that is classified as "failure."
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Dec 2018 (estimated)
- Primary completion23 Apr 2019
- Study completion23 Apr 2019
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Model description
- This is a prospective randomized comparative outcomes study, in which all subjects who fit the inclusion and exclusion criteria and who agreed to be part of the study will be randomized to either Allograft or Cohere PEEK fusion group and will be followed for approximately 12 months following surgery according to the standard-of-care.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Haglund, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187171
- Sponsor's protocol ID
- Pro00083342
- Status last verified
- May 2019
- First submitted
- 12 Jun 2017
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes After ACDF Using Allograft Fusion Versus PEEK Fusion: a Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03187171
- Acronym / sponsor ID
- Pro00083342
- Keywords
- Anterior Cervical Spine Fusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- 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 research protocol seeks to compare radiological and clinical outcomes of cervical spine disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF) using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device.
This clinical study presents little to no additional risk to study subjects beyond those associated with standard-of-care ACDF surgery. Adults age 18 and over who are undergoing an ACDF procedure will be enrolled in the study. The study consists of a completing a series of questionnaires and obtaining radiographs. The primary endpoint of the study will be the rate of successful spinal fusion for each group. For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to the device used and/or procedures performed.
Detailed description
This is a prospective randomized comparative outcomes study, in which all subjects who fit the inclusion and exclusion criteria and who agreed to be part of the study will be randomized to either Allograft or Cohere polyetheretherketone (PEEK) fusion group and will be followed for approximately 12 months following surgery according to the standard-of-care.
Pain and function will be assessed using neck disability index (NDI), 36-Item Short Form Survey (SF-36), and Numeric Rating Scale (NRS). A trained study team member will record a standardized neurologic examination, including motor, sensory, and reflexes. Neurologic success is defined as maintenance or improvement of all 3 neurologic parameters (motor, sensory, and reflexes). The clinical results will also be assessed using the Japanese Orthopedic Association (JOA) scoring system for cervical myelopathy.
Flexion and extension radiographs will be obtained pre-operatively, at 6-months and 12-months after surgery. A CT scan will be obtained at 6 months, if fusion has occurred no CT is needed at 12 months, if fusion did not occur another computerized tomography (CT) scan will obtained at 12 months. From previous literature, successful fusion is defined as ≤2° of angular motion on lateral flexion and extension radiographs, the presence of bridging trabecular bone between the vertebrae being fused, and the absence of any radiolucent zones spanning more than 50% of the allograft surface. Two independent blinded radiologists will assess the radiographs. In the event of disagreement about fusion healing, a third independent reading will be obtained from a third radiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized comparative outcomes study, in which all subjects who fit the inclusion and exclusion criteria and who agreed to be part of the study will be randomized to either Allograft or Cohere PEEK fusion group and will be followed for approximately 12 months following surgery according to the standard-of-care.
| Arm | Type | Receives |
|---|---|---|
| Allograft Fusion Group | Active comparator | Other: Allograft FusionThe anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft. |
| Cohere PEEK Fusion Group | Active comparator | Device: Cohere PEEK Fusion GroupThe anterior approach to the cervical spine for discectomy and fusion by the insertion of a Cohere porous PEEK fusion device. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or more years of age
- Able to provide informed consent
- Has documented diagnosis of cervical spine radiculopathy and/or myelopathy
- Is undergoing standard-of-care ACDF
Key exclusion criteria (5 listed)
- Prior cervical spine surgery
- Single-level ACDF
- Has a systemic infection or cervical spine infection
- Has a medical condition that may interfere with bone and soft tissue healing
- Any condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.
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 |
|---|---|---|
| Allograft FusionACDF is a surgical technique used to treat a variety of cervical spine disorders, such as nerve root or spinal cord compression, cervical spondylosis, and cervical spinal stenosis. The anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft was first described by Robinson and Smith in 1955. In 1958, Cloward described a wide anterior cylindrical discectomy performed with a special reamer combined with anterior fusion by the insertion of autologous iliac bone graft of the same shape. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF. | Other | Allograft Fusion Group |
| Cohere PEEK Fusion GroupAlso: Fusion Device, PEEK CageBagby et al. developed the first interbody fusion cage. Cages of different shapes and materials are used to perform ACDF which, in some cases, could be associated with plate fixation. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF. | Device | Cohere PEEK Fusion Group |
Primary outcome
Rate of successful fusion.
Time frame: 18 months
To compare post-operative bone fusion following standard-of-care ACDF using allograft fusion or Cohere porous PEEK fusion.
1 secondary outcome
Overall success rate - composite score.
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- 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.
Michael Haglund, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Allograft Fusion and Cohere PEEK Fusion Group in people with Cervical Spine Disc Disease and Surgery, run by Duke University.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 May 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of successful fusion. (time frame: 18 months). 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 13 May 2019.