Screw-Integrated vs Traditional Cervical Cages in ACDF for Degenerative Disc Disease

Official title

Comparative Study Between Cervical Cage With Screws and Traditional Cage in Anterior Cervical Discectomy and Fusion (ACDF) for Treatment of Cervical Degenerative Disc Disease (CDDD)

Overview

This study is a prospective, comparative clinical trial conducted at Assiut University Hospitals to evaluate the effectiveness of two different interbody fusion devices in patients with Cervical Degenerative Disc Disease (CDDD). The primary objective is to compare cervical cages with integrated screws against traditional stand-alone cervical cages during single or double-level Anterior Cervical Discectomy and Fusion (ACDF). While ACDF is the gold standard for CDDD, traditional cages can sometimes lead to complications like subsidence or incomplete fusion; integrated screw designs aim to provide immediate stability and reduce these risks. Investigators will assess 40 patients over a 12-month follow-up period, focusing on primary outcomes of radiological interbody fusion using the Daniel Riew grading system. Secondary outcomes include the maintenance of cervical alignment (Ishihara Index), change in segmental angles (Cobb's method), disc height restoration, and clinical improvements in pain and function measured by the Visual Analog Scale (VAS) and Neck Disability Index (NDI). The study's rationale is to provide clearer evidence on whether screw-integrated cages offer superior radiological and clinical outcomes to help guide future surgical preferences

Detailed description

Cervical degenerative disc disease (CDDD) is a common degenerative spinal disorder and a well-recognized cause of neck pain, cervical radiculopathy, and myelopathy. In patients who fail to respond to conservative treatment, anterior cervical discectomy and fusion (ACDF) is considered the gold standard surgical procedure for single-level disease, as originally described and validated in several classical and long-term studies. The main objectives of ACDF include adequate neural decompression, restoration of disc height, maintenance of cervical alignment, and achievement of solid interbody fusion.

Various interbody fusion devices have been developed to improve fusion outcomes. The traditional standalone cervical cage has demonstrated acceptable clinical results; however, several authors have reported potential complications such as cage subsidence, segmental kyphosis, and delayed or incomplete fusion. To overcome these limitations, cervical cages with integrated screw fixation and zero-profile devices have been introduced to provide immediate segmental stability and reduce micromotion at the fusion site, as supported by biomechanical and clinical evidence.

Available data from the literature show inconsistent results regarding the superiority of screw-integrated cages compared to traditional cages in single-level ACDF. While some studies reported improved radiological stability, better maintenance of cervical lordosis, and higher fusion rates with screw-fixed cages, other studies demonstrated comparable clinical and radiological outcomes between both techniques. Currently, the choice of fusion device is largely based on surgeon preference rather than definitive evidence. Therefore, the rationale of this research is to conduct a comparative evaluation of cervical cages with screws versus traditional cervical cages in ACDF, aiming to clarify their impact on fusion, alignment, and clinical outcomes

Interventions

• Device cervical cage with integrated screws
  Anterior Cervical Discectomy and Fusion (ACDF) procedure performed using a cervical cage that features integrated screw fixation. This device provides immediate biomechanical stability without the need for an additional anterior plate
• Device traditional standalone cervical cage
  Standard Anterior Cervical Discectomy and Fusion (ACDF) procedure using a traditional standalone interbody fusion cage (without integrated screws). This serves as the control intervention to compare stability and fusion rates

Primary outcome measures

• Radiological cervical interbody fusion. [Time frame: 3, 6, and 12 months postoperatively]

Secondary outcome measures (6)

• Maintenance of cervical alignment [Time frame: Preoperatively, immediately postoperatively, and at 3, 6, and 12 months.]
• Change in segmental alignment at the operated level [Time frame: preoperatively and at 3, 6 and 12 months postoperatively]
• Restoration and maintenance of intervertebral disc height [Time frame: Preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively]
• Cage subsidence [Time frame: 3, 6, and 12 months postoperatively]
• Implant related complications [Time frame: Each postoperative follow up visit (3, 6, and 12 months)]
• Pain intensity and functional outcome [Time frame: 3, 6, and 12 months postoperatively]

Eligibility criteria

Inclusion criteria

• Patients aged above 18 years old.
• Clinical diagnosis of cervical degenerative disc disease (CDDD).
• Single or double level cervical degenerative disc disease (CDDD) confirmed by MRI
• Failure of conservative treatment for at least 6 weeks.
• Patients indicated for Anterior Cervical Discectomy and Fusion (ACDF).
• Availability of complete preoperative and postoperative clinical and radiological data.
• Willing and able to provide informed consent.

Exclusion criteria

• Previous cervical spine surgery.
• Mutli-level (more than double level) cervical degenerative disc disease (CDDD).
• Significant cervical instability requiring additional posterior fixation
• Cervical trauma, fracture, or spinal infection.
• Cervical tumors or inflammatory spinal disease.
• Severe cervical deformity (fixed kyphosis)
• Osteoporosis or metabolic bone disease.
• Pregnancy
• Psychiatric illness or substance abuse that would compromise follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Song KJ, Taghavi CE, Lee KB, Song JH, Eun JP. The efficacy of plate construct augmentation versus cage alone in anterior cervical fusion. Spine (Phila Pa 1976). 2009 Dec 15;34(26):2886-92. doi: 10.1097/BRS.0b013e3181b64f2c. PMID 19949367
• Nunley PD, Jawahar A, Kerr EJ, Gordon CJ, Cavanaugh DA, Howard C. Choice of fusion device in ACDF: standalone cage versus anterior plate. Spine J. 2013;13(10):1227- 1234
• Hee HT, Majd ME, Holt RT, Whitecloud TS 3rd, Pienkowski D. Complications of multilevel cervical corpectomies and reconstruction with titanium cages and anterior plating. J Spinal Disord Tech. 2003 Feb;16(1):1-8; discussion 8-9. doi: 10.1097/00024720-200302000-00001. PMID 12571477
• Wu WJ, Jiang LS, Liang Y, Dai LY. Cage subsidence does not, but cervical lordosis improvement does affect the long-term results of anterior cervical fusion with stand-alone cage for degenerative cervical disc disease: a retrospective study. Eur Spine J. 2012 Jul;21(7):1374-82. doi: 10.1007/s00586-011-2131-9. Epub 2011 Dec 29. PMID 22205113
• Hofstetter CP, Kesavabhotla K, Boockvar JA. Zero-profile Anchored Spacer Reduces Rate of Dysphagia Compared With ACDF With Anterior Plating. J Spinal Disord Tech. 2015 Jun;28(5):E284-90. doi: 10.1097/BSD.0b013e31828873ed. PMID 23429316
• Scholz M, Schnake KJ, Pingel A, Hoffmann R, Kandziora F. A new zero-profile implant for stand-alone anterior cervical interbody fusion. Clin Orthop Relat Res. 2011 Mar;469(3):666-73. doi: 10.1007/s11999-010-1597-9. PMID 20882376
• Yang JJ, Yu CH, Chang BS, Yeom JS, Lee JH, Lee CK. Subsidence and nonunion after anterior cervical interbody fusion using a stand-alone polyetheretherketone (PEEK) cage. Clin Orthop Surg. 2011 Mar;3(1):16-23. doi: 10.4055/cios.2011.3.1.16. Epub 2011 Feb 15. PMID 21369474
• Bartels RH, Donk RD, Feuth T. Subsidence of stand-alone cervical carbon fiber cages. Neurosurgery. 2006 Mar;58(3):502-8; discussion 502-8. doi: 10.1227/01.NEU.0000197258.30821.50. PMID 16528190

Identifiers

NCT: NCT07430163 · CDDD_Treatment

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗