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

NCT03312192 | Withdrawn FDA Device

• 1 other identifier: 14021901
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Degenerative Disc Disease; Cervical Spine Degeneration

Keywords

Anterior Cervical Discectomy and Fusion; Stand-Alone Cage; Anterior Plating

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (4)

• Dysphagia

  6 months

• Fusion Rates

  6 months

• Clinical Improvement - Change in baseline 12-item Short Form (SF-12) Health Survey at 6 months

  6 months

• Clinical Improvement - Change in baseline Oswestry Disability Index (ODI) at 6 months

  6 months

Other Outcomes (2)

• Adverse Events

  1 year

• Narcotics Consumption

  3 days

Study Arms (2)

Plate and Cage

ACTIVE COMPARATOR

ACDF with interbody cage and anterior plating.

Device: Interbody Cage and Anterior Plating

Stand Alone Cage

ACTIVE COMPARATOR

ACDF with stand alone interbody cage without anterior plating

Device: Interbody Cage

Interventions

Interbody Cage DEVICE

Anterior cervical discectomy and fusion with interbody cage placement

Stand Alone Cage

Interbody Cage and Anterior Plating DEVICE

Anterior cervical discectomy and fusion with interbody cage placement and anterior plating

Plate and Cage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cervical spine trauma

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (9)

• 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.

  PMID: 23897053 BACKGROUND

• 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.

  PMID: 23890389 BACKGROUND

• 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.

  PMID: 22367466 BACKGROUND

• 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.

  PMID: 22872219 BACKGROUND

• 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.

  PMID: 15541666 BACKGROUND

• 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.

  PMID: 23281466 BACKGROUND

• 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.

  PMID: 22885835 BACKGROUND

• 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.

  PMID: 17532499 BACKGROUND

• 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.

  PMID: 9657188 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kern Singh, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Manger

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: October 17, 2017
• Study Start: July 17, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (1)