Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT
Primary Purpose
Cervical Degenerative Disc Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical spine surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Degenerative Disc Disease focused on measuring Cervical Degenerative Disc Disease, Dynamic Cervical Implant, Anterior Cervical Discectomy And Fusion
Eligibility Criteria
Inclusion Criteria:
- Single or multiple symptomatic cervical DDD with radiculopathy and\or mylopathy not responding to non-surgical management
- Age older than 18 years
Exclusion Criteria:
- ossification of posterior longitudinal ligament
- facet arthritis
- lack of motion or instability at the level of surgery
- fracture
- infection
- tumors
- osteoprosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group (1) (ACDF)
Group (2) (DCI)
Arm Description
All patients on this group will undergo Anterior Cervical Discectomy And Fusion
All patients on this group will undergo Dynamic Cervical Implant
Outcomes
Primary Outcome Measures
Radiological outcome
MRI grading for the degree of ASD (Mario Matsumato grading)
Secondary Outcome Measures
Clinical outcome
1-Neck Disability Index (NDI) : 10 item score from 0 to 5 maximum score is 50 , high score is worse
Radiological outcome (Plain x-ray)
1- Cervical sagittal alignment C2 to C7 (Cobb angle)
5-implant fusion described as a less than 1-mm motion between the tips of the spinous processes in dynamic radiographs and/or the presence of bridging bony trabeculae.
Radiological outcome (MSCT)
1-implant fusion
clinical outcome
Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse
radiological outcome
2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05522010
Brief Title
Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT
Official Title
Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 25, 2022 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
TO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)
Detailed Description
Anterior cervical discectomy and fusion (ACDF) is an effective and safe treatment for patients with radiculopathy and myelopathy. However, in the untreated levels adjacent to a fusion, increased motion and elevated intradiscal pressures have been reported. Some investigators have postulated that these changes may lead to an increased risk of adjacent segment degeneration (ASD). Limitations and problems with ACDF have led some investigators to explore the motion-preserving surgeries, such as cervical total disk replacement (TDR). Although TDR has been shown to reduce adjacent-level intra discal pressures and provide a more physiological overall cervical but also index- and adjacent-level range of motion (ROM) while maintaining sagittal alignment. Recent studies have also highlighted the potential limitations of TDR. Dynamic cervical implant (DCI) is a type of anterior decompression and cervical non-fusion implant that was initially conceived as a method to combine the potential advantages of fusion and TDR. The DCI is intended to provide controlled, limited flexion and extension-the primary motions in the sub axial cervical spine-that is greater than that seen with fusion, but less than that achieved with TDR .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Degenerative Disc Disease
Keywords
Cervical Degenerative Disc Disease, Dynamic Cervical Implant, Anterior Cervical Discectomy And Fusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A calculated minimum sample of 50 patients with single or multiple symptomatic cervical DDD with radiculopathy and\or myelopathy not responding to non-surgical management will be needed. The sample will be randomly assigned for one of two equal groups (Group I (n=25); will undergo ACDF and Group II (n=25) will undergo DCI to detect an effect size of 0.42 in the rate of adjacent segment degeneration (main clinical and radiological outcomes), with an error probability of 0.05 and 80%
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (1) (ACDF)
Arm Type
Active Comparator
Arm Description
All patients on this group will undergo Anterior Cervical Discectomy And Fusion
Arm Title
Group (2) (DCI)
Arm Type
Active Comparator
Arm Description
All patients on this group will undergo Dynamic Cervical Implant
Intervention Type
Procedure
Intervention Name(s)
Cervical spine surgery
Intervention Description
A standard anterior approach was made with discectomy sparing the cartilage, and with foraminal decompression. Complete excision of the posterior longitudinal ligament was routinely performed to complete neural decompression. Trial inserters were used to identify the proper implant size. Device under sizing may lead to poor fixation and implant migration. The largest possible device that can be safely placed should be selected to maximize device- endplate contact and to gain support from the apophyseal rim. The teeth of the implant were optimally fixated to the endplate via Caspar pin compression following device insertion. The device may be replaced or changed using the same insertion instrument if final imaging demonstrated suboptimal positioning. Rinsing the implanted disc space removes rests of blood and bone dust, all potentially promoting HO
Primary Outcome Measure Information:
Title
Radiological outcome
Description
MRI grading for the degree of ASD (Mario Matsumato grading)
Time Frame
At 1 year follow up.
Secondary Outcome Measure Information:
Title
Clinical outcome
Description
1-Neck Disability Index (NDI) : 10 item score from 0 to 5 maximum score is 50 , high score is worse
Time Frame
At 3 month .
Title
Radiological outcome (Plain x-ray)
Description
1- Cervical sagittal alignment C2 to C7 (Cobb angle)
5-implant fusion described as a less than 1-mm motion between the tips of the spinous processes in dynamic radiographs and/or the presence of bridging bony trabeculae.
Time Frame
at 6 month.
Title
Radiological outcome (MSCT)
Description
1-implant fusion
Time Frame
At 1 year .
Title
clinical outcome
Description
Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse
Time Frame
At 3 month .
Title
radiological outcome
Description
2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment
Time Frame
at 6 month .
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Single or multiple symptomatic cervical DDD with radiculopathy and\or mylopathy not responding to non-surgical management
Age older than 18 years
Exclusion Criteria:
ossification of posterior longitudinal ligament
facet arthritis
lack of motion or instability at the level of surgery
fracture
infection
tumors
osteoprosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Saleh El Attar, Master
Phone
01014919050
Email
attar@med.aun.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
16205349
Citation
Irwin ZN, Hilibrand A, Gustavel M, McLain R, Shaffer W, Myers M, Glaser J, Hart RA. Variation in surgical decision making for degenerative spinal disorders. Part II: cervical spine. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2214-9. doi: 10.1097/01.brs.0000181056.76595.f7.
Results Reference
background
PubMed Identifier
9704371
Citation
Fuller DA, Kirkpatrick JS, Emery SE, Wilber RG, Davy DT. A kinematic study of the cervical spine before and after segmental arthrodesis. Spine (Phila Pa 1976). 1998 Aug 1;23(15):1649-56. doi: 10.1097/00007632-199808010-00006.
Results Reference
background
PubMed Identifier
9253091
Citation
Hilibrand AS, Yoo JU, Carlson GD, Bohlman HH. The success of anterior cervical arthrodesis adjacent to a previous fusion. Spine (Phila Pa 1976). 1997 Jul 15;22(14):1574-9. doi: 10.1097/00007632-199707150-00009.
Results Reference
background
PubMed Identifier
28002345
Citation
Shao MM, Chen CH, Lin ZK, Wang XY, Huang QS, Chi YL, Wu AM. Comparison of the more than 5-year clinical outcomes of cervical disc arthroplasty versus anterior cervical discectomy and fusion: A protocol for a systematic review and meta-analysis of prospective randomized controlled trials. Medicine (Baltimore). 2016 Dec;95(51):e5733. doi: 10.1097/MD.0000000000005733. Erratum In: Medicine (Baltimore). 2017 Feb 24;96(8):e6219.
Results Reference
background
PubMed Identifier
23140129
Citation
Coric D, Kim PK, Clemente JD, Boltes MO, Nussbaum M, James S. Prospective randomized study of cervical arthroplasty and anterior cervical discectomy and fusion with long-term follow-up: results in 74 patients from a single site. J Neurosurg Spine. 2013 Jan;18(1):36-42. doi: 10.3171/2012.9.SPINE12555. Epub 2012 Nov 9.
Results Reference
background
PubMed Identifier
27314663
Citation
Zou S, Gao J, Xu B, Lu X, Han Y, Meng H. Anterior cervical discectomy and fusion (ACDF) versus cervical disc arthroplasty (CDA) for two contiguous levels cervical disc degenerative disease: a meta-analysis of randomized controlled trials. Eur Spine J. 2017 Apr;26(4):985-997. doi: 10.1007/s00586-016-4655-5. Epub 2016 Jun 17.
Results Reference
background
PubMed Identifier
28304237
Citation
Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Copay AG, Nian H, Harrell FE Jr. Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months. J Neurosurg Spine. 2017 Jun;26(6):653-667. doi: 10.3171/2016.10.SPINE16264. Epub 2017 Mar 17.
Results Reference
background
PubMed Identifier
27015130
Citation
Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25. Erratum In: J Neurosurg Spine. 2016 Aug;25(2):280.
Results Reference
background
PubMed Identifier
28422837
Citation
Wu TK, Wang BY, Meng Y, Ding C, Yang Y, Lou JG, Liu H. Multilevel cervical disc replacement versus multilevel anterior discectomy and fusion: A meta-analysis. Medicine (Baltimore). 2017 Apr;96(16):e6503. doi: 10.1097/MD.0000000000006503.
Results Reference
background
PubMed Identifier
27679431
Citation
Lu VM, Zhang L, Scherman DB, Rao PJ, Mobbs RJ, Phan K. Treating multi-level cervical disc disease with hybrid surgery compared to anterior cervical discectomy and fusion: a systematic review and meta-analysis. Eur Spine J. 2017 Feb;26(2):546-557. doi: 10.1007/s00586-016-4791-y. Epub 2016 Sep 27.
Results Reference
background
PubMed Identifier
29605899
Citation
Kelly MP, Eliasberg CD, Riley MS, Ajiboye RM, SooHoo NF. Reoperation and complications after anterior cervical discectomy and fusion and cervical disc arthroplasty: a study of 52,395 cases. Eur Spine J. 2018 Jun;27(6):1432-1439. doi: 10.1007/s00586-018-5570-8. Epub 2018 Mar 31.
Results Reference
background
PubMed Identifier
16506475
Citation
Pickett GE, Sekhon LH, Sears WR, Duggal N. Complications with cervical arthroplasty. J Neurosurg Spine. 2006 Feb;4(2):98-105. doi: 10.3171/spi.2006.4.2.98.
Results Reference
background
PubMed Identifier
24411326
Citation
Li Z, Yu S, Zhao Y, Hou S, Fu Q, Li F, Hou T, Zhong H. Clinical and radiologic comparison of dynamic cervical implant arthroplasty versus anterior cervical discectomy and fusion for the treatment of cervical degenerative disc disease. J Clin Neurosci. 2014 Jun;21(6):942-8. doi: 10.1016/j.jocn.2013.09.007. Epub 2013 Nov 4.
Results Reference
background
PubMed Identifier
24474644
Citation
Wang L, Song YM, Liu LM, Liu H, Li T. Clinical and radiographic outcomes of dynamic cervical implant replacement for treatment of single-level degenerative cervical disc disease: a 24-month follow-up. Eur Spine J. 2014 Aug;23(8):1680-7. doi: 10.1007/s00586-014-3180-7. Epub 2014 Jan 29.
Results Reference
background
Learn more about this trial
Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT
We'll reach out to this number within 24 hrs