Cervical FusionNCT04041583
Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
An observational study of Cervical Fusion, run by Ohio State University at 1 site in United States.
Trial summary
This is a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Data will be collected from medical records for up to 730 days after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Fusion
- What is being tested?
- Cervical Interfacet Spacers
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing posterior cervical arthrodesis procedures for spondylosis supplemented with CIS involving three or more segmental levels in the subaxial cervicothoracic spine (between C2-upper thoracic)
Who may be able to join
- ≥ 18 years old
- Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).
- Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
Who cannot join
- Traumatic injury
- Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
- Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- Recent (<3 yrs) or co-incident spinal tumor or infection
- Concurrent involvement in another investigational drug or device study that could confound study data
- History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
- Subjects who are pregnant or plan to become pregnant in the next 24 months
- Prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Aladdin A Alqaisi, MS, 614-814-7007, Aladdin.Alqaisi@osumc.edu
Allie Garvin, BS, 614-688-8304, allison.garvin@osumc.edu
About this study
This is a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Data will be collected from medical records for up to 730 days after surgery. Data to be collected will be demographic, preoperative clinical information, surgical details, and radiographic information. Patients will also undergo a non-standard of care CT scan 2 years after surgery.
Read the detailed description
Background and Rationale
Posterior cervical fusion surgeries are performed for degenerative cervical conditions, cervical deformity, cervical tumors, and cervical trauma. They are preferred over an anterior approach when the pathology is located posterior to the spinal cord or when multiple levels must be addressed. Degenerative cervical spondylosis contributes to loss of disc height, facet arthropathy and hypertrophy, and retrolisthesis of the vertebral bodies, all of which can lead to foraminal stenosis, or narrowing around the exiting nerve roots. This is often accompanied by loss of cervical lordosis. During a posterior fusion operation, the restoration of cervical lordosis can worsen this foraminal stenosis and lead to iatrogenic radiculopathy with and estimated incidence between 2.4-50%. Cadaveric studies have shown the insertion of interfacet spacers in the cervical spine increase foraminal height, and serve to indirectly decompress the exiting nerve roots. Another common complication of cervical spine surgery is C5 palsy, which has been reported in 4.6% of patient undergoing posterior cervical spine decompressive procedures, including decompression and fusion. Patients suffering from iatrogenic C5 palsy have significantly increased recovery times, and often require additional services such as imaging studies (CT, MRI) and increased need for physical and occupational therapy, thus increasing costs. Given the ability to decompress the neuroforamen with interfacet spacers, they could potentially be an effective technique for reducing the incidence of C5 palsy.
The use of cervical interfacet spacers (CIS; CORNERSTONE Facet MicroGrafts, Medtronic, Minneapolis, MN) is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion. Current techniques for posterior cervical fusion rely on graft placement using bone extenders placed in the posterolateral space, which is not under a compressive load. Wolfe's law dictates that certain amounts of loading of bone grafts is required to achieve bony fusion. Therefore, the use of CIS could potentially increase fusion rates after posterior cervical arthrodesis procedures and reduce or eliminate the need for use of bone graft extenders. Reassuringly, radiologic studies have shown that despite the increase in foraminal height, the use of CIS does not lead to loss of cervical lordosis.
Study Objective
To date, there have been no prospective studies examining the use of cervical interfacet spacers. The investigators propose to undertake a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS.
Primary Outcome Measures The primary outcome measures will include (i) the rate of cervical fusion measured on post-operative radiographs and CT scans performed at 2-years and (ii) cervical sagittal alignment parameters as measured on post-operative radiographs.
Secondary Outcome Measures The secondary outcome measures will include post-operative patient reported outcomes including NRS, NDI, and SF-36 RAND. As well, all neurological adverse events will be prospectively collected.
- Conditions
- Cervical Fusion
- Being tested
- Cervical Interfacet Spacers
- Medical subject headings
- Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Interfacet SpacersDevice
Also called (CIS; CORNERSTONE Facet MicroGrafts, Medtronic, Minneapolis, MN)
The use of Cervical Interfacet Spacers is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis [2]. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion [2].
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Patients undergoing posterior cervical arthrodesis procedures for spondylosis supplemented with CIS involving three or more segmental levels in the subaxial cervicothoracic spine (between C2-upper thoracic) Receives: Device: Cervical Interfacet Spacers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Fusion
Cervical Fusion Measured on Post-Operative Radiographs and CT scans
Measured: 2-Years
Cervical Sagittal Alignment Parameters
Cervical Sagittal Alignment Parameters measured on post-operative radiographs
Measured: 2-Years
Secondary outcomes (4)
NRS
Numerical Rating Score for Pain from 0-10 where lower values represent a better outcome
Measured: 2-Years
NDI
Neck Disability Index from 0-100% where lower values represent a better outcome
Measured: 2-Years
SF-36 RAND
Quality of Life Measures from 0-100 where higher values represent a better outcome
Measured: 2-Years
Neurological Adverse Events
Adverse Events
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 posted1 Aug 2019
- Study start1 Sep 2019
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical FusionStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Andrew Grossbach, Ohio State University
- Investigators
- Andrew Grossbach, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041583
- Sponsor's protocol ID
- 2019H0015
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tan LA, Gerard CS, Anderson PA, Traynelis VC. Effect of machined interfacet allograft spacers on cervical foraminal height and area. J Neurosurg Spine. 2014 Feb;20(2):178-82. doi: 10.3171/2013.11.SPINE131. Epub 2013 Dec 13.
PubMed 24328759Kasliwal MK, Corley JA, Traynelis VC. Posterior Cervical Fusion Using Cervical Interfacet Spacers in Patients With Symptomatic Cervical Pseudarthrosis. Neurosurgery. 2016 May;78(5):661-8. doi: 10.1227/NEU.0000000000001087.
PubMed 26516824Mummaneni PV, Meyer SA, Wu JC. Biological approaches to spinal instrumentation and fusion in spinal deformity surgery. Clin Neurosurg. 2011;58:110-6. doi: 10.1227/neu.0b013e3182270009. No abstract available.
PubMed 21916134Tan LA, Straus DC, Traynelis VC. Cervical interfacet spacers and maintenance of cervical lordosis. J Neurosurg Spine. 2015 May;22(5):466-9. doi: 10.3171/2014.10.SPINE14192. Epub 2015 Feb 13.
PubMed 25679233Fogel GR, Toohey JS, Neidre A, Brantigan JW. Fusion assessment of posterior lumbar interbody fusion using radiolucent cages: X-ray films and helical computed tomography scans compared with surgical exploration of fusion. Spine J. 2008 Jul-Aug;8(4):570-7. doi: 10.1016/j.spinee.2007.03.013. Epub 2007 May 29.
PubMed 17544854Turel MK, Kerolus MG, Traynelis VC. Machined cervical interfacet allograft spacers for the management of atlantoaxial instability. J Craniovertebr Junction Spine. 2017 Oct-Dec;8(4):332-337. doi: 10.4103/jcvjs.JCVJS_87_17.
PubMed 29403245
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
- ClinicalTrials.gov ID
- NCT04041583
- Acronym / sponsor ID
- 2019H0015
- Conditions
- Cervical Fusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 1 Aug 2019 (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 is a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Data will be collected from medical records for up to 730 days after surgery. Data to be collected will be demographic, preoperative clinical information, surgical details, and radiographic information. Patients will also undergo a non-standard of care CT scan 2 years after surgery.
Detailed description
Background and Rationale
Posterior cervical fusion surgeries are performed for degenerative cervical conditions, cervical deformity, cervical tumors, and cervical trauma. They are preferred over an anterior approach when the pathology is located posterior to the spinal cord or when multiple levels must be addressed. Degenerative cervical spondylosis contributes to loss of disc height, facet arthropathy and hypertrophy, and retrolisthesis of the vertebral bodies, all of which can lead to foraminal stenosis, or narrowing around the exiting nerve roots. This is often accompanied by loss of cervical lordosis. During a posterior fusion operation, the restoration of cervical lordosis can worsen this foraminal stenosis and lead to iatrogenic radiculopathy with and estimated incidence between 2.4-50%. Cadaveric studies have shown the insertion of interfacet spacers in the cervical spine increase foraminal height, and serve to indirectly decompress the exiting nerve roots. Another common complication of cervical spine surgery is C5 palsy, which has been reported in 4.6% of patient undergoing posterior cervical spine decompressive procedures, including decompression and fusion. Patients suffering from iatrogenic C5 palsy have significantly increased recovery times, and often require additional services such as imaging studies (CT, MRI) and increased need for physical and occupational therapy, thus increasing costs. Given the ability to decompress the neuroforamen with interfacet spacers, they could potentially be an effective technique for reducing the incidence of C5 palsy.
The use of cervical interfacet spacers (CIS; CORNERSTONE Facet MicroGrafts, Medtronic, Minneapolis, MN) is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion. Current techniques for posterior cervical fusion rely on graft placement using bone extenders placed in the posterolateral space, which is not under a compressive load. Wolfe's law dictates that certain amounts of loading of bone grafts is required to achieve bony fusion. Therefore, the use of CIS could potentially increase fusion rates after posterior cervical arthrodesis procedures and reduce or eliminate the need for use of bone graft extenders. Reassuringly, radiologic studies have shown that despite the increase in foraminal height, the use of CIS does not lead to loss of cervical lordosis.
Study Objective
To date, there have been no prospective studies examining the use of cervical interfacet spacers. The investigators propose to undertake a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS.
Primary Outcome Measures The primary outcome measures will include (i) the rate of cervical fusion measured on post-operative radiographs and CT scans performed at 2-years and (ii) cervical sagittal alignment parameters as measured on post-operative radiographs.
Secondary Outcome Measures The secondary outcome measures will include post-operative patient reported outcomes including NRS, NDI, and SF-36 RAND. As well, all neurological adverse events will be prospectively collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Device: Cervical Interfacet SpacersPatients undergoing posterior cervical arthrodesis procedures for spondylosis supplemented with CIS involving three or more segmental levels in the subaxial cervicothoracic spine (between C2-upper thoracic) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing posterior cervical arthrodesis procedures for spondylosis supplemented with CIS involving three or more segmental levels in the subaxial cervicothoracic spine (between C2-upper thoracic)
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).
- Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
Key exclusion criteria (8 listed)
- Traumatic injury
- Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
- Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- Recent (<3 yrs) or co-incident spinal tumor or infection
- Concurrent involvement in another investigational drug or device study that could confound study data
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 Interfacet SpacersAlso: (CIS; CORNERSTONE Facet MicroGrafts, Medtronic, Minneapolis, MN)The use of Cervical Interfacet Spacers is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis [2]. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion [2]. | Device | Arm 1 |
Primary outcome
Cervical Fusion
Time frame: 2-Years
Cervical Fusion Measured on Post-Operative Radiographs and CT scans
Cervical Sagittal Alignment Parameters
Time frame: 2-Years
Cervical Sagittal Alignment Parameters measured on post-operative radiographs
4 secondary outcomes
NRS
Time frame: 2-Years
NDI
Time frame: 2-Years
SF-36 RAND
Time frame: 2-Years
Neurological Adverse Events
Time frame: 2-Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 24328759Tan LA, Gerard CS, Anderson PA, Traynelis VC. Effect of machined interfacet allograft spacers on cervical foraminal height and area. J Neurosurg Spine. 2014 Feb;20(2):178-82. doi: 10.3171/2013.11.SPINE131. Epub 2013 Dec 13.
- Results publication: PubMed 26516824Kasliwal MK, Corley JA, Traynelis VC. Posterior Cervical Fusion Using Cervical Interfacet Spacers in Patients With Symptomatic Cervical Pseudarthrosis. Neurosurgery. 2016 May;78(5):661-8. doi: 10.1227/NEU.0000000000001087.
- Results publication: PubMed 21916134Mummaneni PV, Meyer SA, Wu JC. Biological approaches to spinal instrumentation and fusion in spinal deformity surgery. Clin Neurosurg. 2011;58:110-6. doi: 10.1227/neu.0b013e3182270009. No abstract available.
- Results publication: PubMed 25679233Tan LA, Straus DC, Traynelis VC. Cervical interfacet spacers and maintenance of cervical lordosis. J Neurosurg Spine. 2015 May;22(5):466-9. doi: 10.3171/2014.10.SPINE14192. Epub 2015 Feb 13.
- Results publication: PubMed 17544854Fogel GR, Toohey JS, Neidre A, Brantigan JW. Fusion assessment of posterior lumbar interbody fusion using radiolucent cages: X-ray films and helical computed tomography scans compared with surgical exploration of fusion. Spine J. 2008 Jul-Aug;8(4):570-7. doi: 10.1016/j.spinee.2007.03.013. Epub 2007 May 29.
- Results publication: PubMed 29403245Turel MK, Kerolus MG, Traynelis VC. Machined cervical interfacet allograft spacers for the management of atlantoaxial instability. J Craniovertebr Junction Spine. 2017 Oct-Dec;8(4):332-337. doi: 10.4103/jcvjs.JCVJS_87_17.
- 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.
Andrew Grossbach, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Fusion, run by Ohio State University at 1 site in United States.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aladdin A Alqaisi, MPH (614-814-7007, Aladdin.Alqaisi@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Fusion (time frame: 2-Years). 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?
On the ClinicalTrials.gov record for NCT04041583, which also lists 6 linked publications.
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 16 Oct 2026.