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Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.

Primary Purpose

Degenerative Disc Disease, Cervical Spine Degeneration

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interbody Cage
Interbody Cage and Anterior Plating
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Anterior Cervical Discectomy and Fusion, Stand-Alone Cage, Anterior Plating

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing a primary 1- to 2-level ACDF

    (a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis

  • Patients able to provide informed consent

Exclusion Criteria:

  • Cervical spine trauma

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Plate and Cage

Stand Alone Cage

Arm Description

ACDF with interbody cage and anterior plating.

ACDF with stand alone interbody cage without anterior plating

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dysphagia
6 month postoperative followup SWAL-QOL score will be compared to baseline
Fusion Rates
Postoperative radiographic studies will be performed at 6 month follow up visit to assess for arthrodesis (fusion) and pseudarthrosis (non-fusion).
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
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

Full Information

First Posted
August 8, 2017
Last Updated
September 8, 2021
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03312192
Brief Title
Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.
Official Title
Stand-Alone Cage Versus Anterior Plating for 1-2 Level Anterior Cervical Discectomy and Fusion. A Clinical and Radiographic Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
poor recruitment
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Cervical Spine Degeneration
Keywords
Anterior Cervical Discectomy and Fusion, Stand-Alone Cage, Anterior Plating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plate and Cage
Arm Type
Active Comparator
Arm Description
ACDF with interbody cage and anterior plating.
Arm Title
Stand Alone Cage
Arm Type
Active Comparator
Arm Description
ACDF with stand alone interbody cage without anterior plating
Intervention Type
Device
Intervention Name(s)
Interbody Cage
Intervention Description
Anterior cervical discectomy and fusion with interbody cage placement
Intervention Type
Device
Intervention Name(s)
Interbody Cage and Anterior Plating
Intervention Description
Anterior cervical discectomy and fusion with interbody cage placement and anterior plating
Primary Outcome Measure Information:
Title
Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Dysphagia
Description
6 month postoperative followup SWAL-QOL score will be compared to baseline
Time Frame
6 months
Title
Fusion Rates
Description
Postoperative radiographic studies will be performed at 6 month follow up visit to assess for arthrodesis (fusion) and pseudarthrosis (non-fusion).
Time Frame
6 months
Title
Clinical Improvement - Change in baseline 12-item Short Form (SF-12) Health Survey at 6 months
Description
SF-12 survey scores at 6 month follow up will be compared to baseline
Time Frame
6 months
Title
Clinical Improvement - Change in baseline Oswestry Disability Index (ODI) at 6 months
Description
ODI survey scores at 6 month follow up will be compared to baseline
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
(a) Intra-operative - Information will be obtained from the operative note. (i) Blood loss, length of surgery, procedural details, complications (b) Post-operative - Information will be obtained from the clinic notes
Time Frame
1 year
Title
Narcotics Consumption
Description
The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents. This information will be measured during the hospitalization.
Time Frame
3 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing a primary 1- to 2-level ACDF (a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis Patients able to provide informed consent Exclusion Criteria: Cervical spine trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kern Singh, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23897053
Citation
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.
Results Reference
background
PubMed Identifier
23890389
Citation
Choi 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.
Results Reference
background
PubMed Identifier
22367466
Citation
Oh 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.
Results Reference
background
PubMed Identifier
22872219
Citation
Lee 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.
Results Reference
background
PubMed Identifier
15541666
Citation
Hilibrand 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.
Results Reference
background
PubMed Identifier
23281466
Citation
Cho 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.
Results Reference
background
PubMed Identifier
22885835
Citation
Kraemer 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.
Results Reference
background
PubMed Identifier
17532499
Citation
Mobbs 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.
Results Reference
background
PubMed Identifier
9657188
Citation
Savolainen 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.
Results Reference
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Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.

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