Degenerative Disc DiseaseNCT03312192
Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.
A study testing Interbody Cage and Interbody Cage and Anterior Plating in people with Degenerative Disc Disease and Cervical Spine Degeneration, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease, Cervical Spine Degeneration
- What is being tested?
- Interbody Cage and Interbody Cage and Anterior Plating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing a primary 1- to 2-level ACDF
- Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
- Patients able to provide informed consent
Who cannot join
- Cervical spine trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Stand-Alone Cage Versus Anterior Plating for 1-2 Level Anterior Cervical Discectomy and Fusion. A Clinical and Radiographic Analysis
The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation. Both of these procedures are commonly performed at Rush with unclear advantage of one procedure over the other. Both have been associated with good to excellent clinical outcomes. The devices used in this study are approved by the Food and Drug Administration (FDA).
Read the detailed description
Anterior cervical discectomy and fusion (ACDF) is one the most common procedures performed by spine surgeons. Although ACDF with autologous bone graft and anterior plating is commonly performed, this procedure may be associated with postoperative dysphagia, significant costs and adjacent segment pathology. To address these concerns, a number of surgeons have opted to utilize an interbody cage in a stand-alone fashion with good to excellent results. However, the published data is limited and currently there in no consensus among spine surgeons regarding the best technique to achieve fusion and improve clinical outcomes in patients with degenerative disc disease in the cervical spine.
- Being tested
- Interbody Cage, Interbody Cage and Anterior Plating
- Keywords
- Anterior Cervical Discectomy and Fusion, Stand-Alone Cage, Anterior Plating
- 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.
Interbody CageDevice
Anterior cervical discectomy and fusion with interbody cage placement
Interbody Cage and Anterior PlatingDevice
Anterior cervical discectomy and fusion with interbody cage placement and anterior plating
| Study group | Role | What they receive |
|---|---|---|
| Plate and Cage | Active comparator | ACDF with interbody cage and anterior plating. Receives: Device: Interbody Cage and Anterior Plating |
| Stand Alone Cage | Active comparator | ACDF with stand alone interbody cage without anterior plating Receives: Device: Interbody Cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain
Patients will be asked to complete the VAS to measure their pain prior to surgery and at their preoperative office visit(s) or just prior to surgery in the preoperative waiting area. Scores at the 6 month follow up office visit will be compared to baseline
Measured: 6 months
Secondary outcomes (4)
Dysphagia
6 month postoperative followup SWAL-QOL score will be compared to baseline
Measured: 6 months
Fusion Rates
Postoperative radiographic studies will be performed at 6 month follow up visit to assess for arthrodesis (fusion) and pseudarthrosis (non-fusion).
Measured: 6 months
Clinical Improvement - Change in baseline 12-item Short Form (SF-12) Health Survey at 6 months
SF-12 survey scores at 6 month follow up will be compared to baseline
Measured: 6 months
Clinical Improvement - Change in baseline Oswestry Disability Index (ODI) at 6 months
ODI survey scores at 6 month follow up will be compared to baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start17 Jul 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- 1\. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Edwards, Rush University Medical Center
- Investigators
- Kern Singh, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312192
- Sponsor's protocol ID
- 14021901
- Status last verified
- Sep 2021
- First submitted
- 8 Aug 2017
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ji GY, Oh CH, Shin DA, Ha Y, Kim KN, Yoon DH, Yudoyono F. Stand-alone Cervical Cages Versus Anterior Cervical Plates in 2-Level Cervical Anterior Interbody Fusion Patients: Analysis of Adjacent Segment Degeneration. J Spinal Disord Tech. 2015 Aug;28(7):E433-8. doi: 10.1097/BSD.0b013e3182a355ad.
PubMed 23897053Choi KC, Ryu KS, Lee SH, Kim YH, Lee SJ, Park CK. Biomechanical comparison of anterior lumbar interbody fusion: stand-alone interbody cage versus interbody cage with pedicle screw fixation -- a finite element analysis. BMC Musculoskelet Disord. 2013 Jul 26;14:220. doi: 10.1186/1471-2474-14-220.
PubMed 23890389Oh JK, Kim TY, Lee HS, You NK, Choi GH, Yi S, Ha Y, Kim KN, Yoon DH, Shin HC. Stand-alone cervical cages versus anterior cervical plate in 2-level cervical anterior interbody fusion patients: clinical outcomes and radiologic changes. J Spinal Disord Tech. 2013 Dec;26(8):415-20. doi: 10.1097/BSD.0b013e31824c7d22.
PubMed 22367466Lee MJ, Dettori JR, Standaert CJ, Ely CG, Chapman JR. Indication for spinal fusion and the risk of adjacent segment pathology: does reason for fusion affect risk? A systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S40-51. doi: 10.1097/BRS.0b013e31826ca9b1.
PubMed 22872219Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J. 2004 Nov-Dec;4(6 Suppl):190S-194S. doi: 10.1016/j.spinee.2004.07.007.
PubMed 15541666Cho SK, Riew KD. Adjacent segment disease following cervical spine surgery. J Am Acad Orthop Surg. 2013 Jan;21(1):3-11. doi: 10.5435/JAAOS-21-01-3.
PubMed 23281466Kraemer P, Fehlings MG, Hashimoto R, Lee MJ, Anderson PA, Chapman JR, Raich A, Norvell DC. A systematic review of definitions and classification systems of adjacent segment pathology. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S31-9. doi: 10.1097/BRS.0b013e31826d7dd6.
PubMed 22885835Mobbs RJ, Rao P, Chandran NK. Anterior cervical discectomy and fusion: analysis of surgical outcome with and without plating. J Clin Neurosci. 2007 Jul;14(7):639-42. doi: 10.1016/j.jocn.2006.04.003.
PubMed 17532499Savolainen S, Rinne J, Hernesniemi J. A prospective randomized study of anterior single-level cervical disc operations with long-term follow-up: surgical fusion is unnecessary. Neurosurgery. 1998 Jul;43(1):51-5. doi: 10.1097/00006123-199807000-00032.
PubMed 9657188
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand-Alone Cage Versus Anterior Plating for 1-2 Level Anterior Cervical Discectomy and Fusion. A Clinical and Radiographic Analysis
- ClinicalTrials.gov ID
- NCT03312192
- Acronym / sponsor ID
- 14021901
- Keywords
- Anterior Cervical Discectomy and Fusion, Stand-Alone Cage, Anterior Plating
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Oct 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.
The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation. Both of these procedures are commonly performed at Rush with unclear advantage of one procedure over the other. Both have been associated with good to excellent clinical outcomes. The devices used in this study are approved by the Food and Drug Administration (FDA).
Detailed description
Anterior cervical discectomy and fusion (ACDF) is one the most common procedures performed by spine surgeons. Although ACDF with autologous bone graft and anterior plating is commonly performed, this procedure may be associated with postoperative dysphagia, significant costs and adjacent segment pathology. To address these concerns, a number of surgeons have opted to utilize an interbody cage in a stand-alone fashion with good to excellent results. However, the published data is limited and currently there in no consensus among spine surgeons regarding the best technique to achieve fusion and improve clinical outcomes in patients with degenerative disc disease in the cervical spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation.
| Arm | Type | Receives |
|---|---|---|
| Plate and Cage | Active comparator | Device: Interbody Cage and Anterior PlatingACDF with interbody cage and anterior plating. |
| Stand Alone Cage | Active comparator | Device: Interbody CageACDF with stand alone interbody cage without anterior plating |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing a primary 1- to 2-level ACDF
- Patients able to provide informed consent
Key exclusion criteria (1 listed)
- Cervical spine trauma
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 |
|---|---|---|
| Interbody CageAnterior cervical discectomy and fusion with interbody cage placement | Device | Stand Alone Cage |
| Interbody Cage and Anterior PlatingAnterior cervical discectomy and fusion with interbody cage placement and anterior plating | Device | Plate and Cage |
Primary outcome
Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain
Time frame: 6 months
Patients will be asked to complete the VAS to measure their pain prior to surgery and at their preoperative office visit(s) or just prior to surgery in the preoperative waiting area. Scores at the 6 month follow up office visit will be compared to baseline
4 secondary outcomes
Dysphagia
Time frame: 6 months
Fusion Rates
Time frame: 6 months
Clinical Improvement - Change in baseline 12-item Short Form (SF-12) Health Survey at 6 months
Time frame: 6 months
Clinical Improvement - Change in baseline Oswestry Disability Index (ODI) at 6 months
Time frame: 6 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 16 Sep 2021.
- Background: PubMed 23897053Ji GY, Oh CH, Shin DA, Ha Y, Kim KN, Yoon DH, Yudoyono F. Stand-alone Cervical Cages Versus Anterior Cervical Plates in 2-Level Cervical Anterior Interbody Fusion Patients: Analysis of Adjacent Segment Degeneration. J Spinal Disord Tech. 2015 Aug;28(7):E433-8. doi: 10.1097/BSD.0b013e3182a355ad.
- Background: PubMed 23890389Choi KC, Ryu KS, Lee SH, Kim YH, Lee SJ, Park CK. Biomechanical comparison of anterior lumbar interbody fusion: stand-alone interbody cage versus interbody cage with pedicle screw fixation -- a finite element analysis. BMC Musculoskelet Disord. 2013 Jul 26;14:220. doi: 10.1186/1471-2474-14-220.
- Background: PubMed 22367466Oh JK, Kim TY, Lee HS, You NK, Choi GH, Yi S, Ha Y, Kim KN, Yoon DH, Shin HC. Stand-alone cervical cages versus anterior cervical plate in 2-level cervical anterior interbody fusion patients: clinical outcomes and radiologic changes. J Spinal Disord Tech. 2013 Dec;26(8):415-20. doi: 10.1097/BSD.0b013e31824c7d22.
- Background: PubMed 22872219Lee MJ, Dettori JR, Standaert CJ, Ely CG, Chapman JR. Indication for spinal fusion and the risk of adjacent segment pathology: does reason for fusion affect risk? A systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S40-51. doi: 10.1097/BRS.0b013e31826ca9b1.
- Background: PubMed 15541666Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J. 2004 Nov-Dec;4(6 Suppl):190S-194S. doi: 10.1016/j.spinee.2004.07.007.
- Background: PubMed 23281466Cho SK, Riew KD. Adjacent segment disease following cervical spine surgery. J Am Acad Orthop Surg. 2013 Jan;21(1):3-11. doi: 10.5435/JAAOS-21-01-3.
- Background: PubMed 22885835Kraemer P, Fehlings MG, Hashimoto R, Lee MJ, Anderson PA, Chapman JR, Raich A, Norvell DC. A systematic review of definitions and classification systems of adjacent segment pathology. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S31-9. doi: 10.1097/BRS.0b013e31826d7dd6.
- Background: PubMed 17532499Mobbs RJ, Rao P, Chandran NK. Anterior cervical discectomy and fusion: analysis of surgical outcome with and without plating. J Clin Neurosci. 2007 Jul;14(7):639-42. doi: 10.1016/j.jocn.2006.04.003.
- Background: PubMed 9657188Savolainen S, Rinne J, Hernesniemi J. A prospective randomized study of anterior single-level cervical disc operations with long-term follow-up: surgical fusion is unnecessary. Neurosurgery. 1998 Jul;43(1):51-5. doi: 10.1097/00006123-199807000-00032.
- Individual participant dataSharing planned: Undecided
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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.
Kern Singh, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interbody Cage and Interbody Cage and Anterior Plating in people with Degenerative Disc Disease and Cervical Spine Degeneration, run by Rush University Medical Center 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 1 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 16 Sep 2021. 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?
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?
Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain (time frame: 6 months). 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 NCT03312192, which also lists 9 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 Sep 2021.