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

NCT05522010 | Unknown

• 1 other identifier: Cervical Degenerative Disease
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cervical Degenerative Disc Disease

Keywords

Cervical Degenerative Disc Disease; Dynamic Cervical Implant; Anterior Cervical Discectomy And Fusion

Outcome Measures

Primary Outcomes (1)

• Radiological outcome

  MRI grading for the degree of ASD (Mario Matsumato grading)

  At 1 year follow up.

Secondary Outcomes (5)

• Clinical outcome

  At 3 month .

• Radiological outcome (Plain x-ray)

  at 6 month.

• Radiological outcome (MSCT)

  At 1 year .

• clinical outcome

  At 3 month .

• radiological outcome

  at 6 month .

Study Arms (2)

Group (1) (ACDF)

ACTIVE COMPARATOR

All patients on this group will undergo Anterior Cervical Discectomy And Fusion

Procedure: Cervical spine surgery

Group (2) (DCI)

ACTIVE COMPARATOR

All patients on this group will undergo Dynamic Cervical Implant

Procedure: Cervical spine surgery

Interventions

Cervical spine surgery PROCEDURE

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

Group (1) (ACDF); Group (2) (DCI)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single or multiple symptomatic cervical DDD with radiculopathy and\\or mylopathy not responding to non-surgical management
• Age older than 18 years

You may not qualify if:

• ossification of posterior longitudinal ligament
• facet arthritis
• lack of motion or instability at the level of surgery
• fracture
• infection
• tumors
• osteoprosis

Sponsors & Collaborators

• Assiut University: lead

Related Publications (14)

• 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.

  PMID: 16205349 BACKGROUND

• 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.

  PMID: 9704371 BACKGROUND

• 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.

  PMID: 9253091 BACKGROUND

• 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.

  PMID: 28002345 BACKGROUND

• 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.

  PMID: 23140129 BACKGROUND

• 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.

  PMID: 27314663 BACKGROUND

• 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.

  PMID: 28304237 BACKGROUND

• 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.

  PMID: 27015130 BACKGROUND

• 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.

  PMID: 28422837 BACKGROUND

• 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.

  PMID: 27679431 BACKGROUND

• 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.

  PMID: 29605899 BACKGROUND

• 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.

  PMID: 16506475 BACKGROUND

• 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.

  PMID: 24411326 BACKGROUND

• 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.

  PMID: 24474644 BACKGROUND

Central Study Contacts

Mahmoud Saleh El Attar, Master

CONTACT

01014919050; attar@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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%

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 30, 2022
• Study Start: August 25, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: August 30, 2022

Record last verified: 2022-08