Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT

Cervical Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05522010
• Other study ID #: Cervical Degenerative Disease
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: Mahmoud Saleh El Attar, Master
• Phone: 01014919050
• Email: attar[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

1. ossification of posterior longitudinal ligament

2. facet arthritis

3. lack of motion or instability at the level of surgery

4. fracture

5. infection

6. tumors

7. osteoprosis

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Procedure:
• Cervical spine surgery
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 ?xation 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 ?xated to the endplate via Caspar pin compression following device insertion. The device may be replaced or changed using the same insertion instrument if ?nal imaging demonstrated suboptimal positioning. Rinsing the implanted disc space removes rests of blood and bone dust, all potentially promoting HO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (14)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Pickett GE, Sekhon LH, Sears WR, Duggal N. Complications with cervical arthroplasty. J Neurosurg Spine. 2006 Feb;4(2):98-105. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological outcome	MRI grading for the degree of ASD (Mario Matsumato grading)	At 1 year follow up.
Secondary	Clinical outcome	1-Neck Disability Index (NDI) : 10 item score from 0 to 5 maximum score is 50 , high score is worse	At 3 month .
Secondary	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.	at 6 month.
Secondary	Radiological outcome (MSCT)	1-implant fusion	At 1 year .
Secondary	clinical outcome	Visual analogue scale (VAS) scores for neck and arm from 0 to 10 score , the higher score is worse	At 3 month .
Secondary	radiological outcome	2- Range of motion (ROM) using Cobb method for cervical spine and functional spine unit of treated segment	at 6 month .