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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screw-Integrated Cage Group | Experimental | 20 patients with cervical degenerative disc disease (CDDD) undergoing single or double-level ACDF using a cervical cage with integrated screw fixation. |
|
| Traditional Cage Group | Active Comparator | 20 patients with cervical degenerative disc disease (CDDD) undergoing single or double-level ACDF using a traditional standalone cervical cage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cervical cage with integrated screws | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological cervical interbody fusion. | Assessment of solid bone fusion at the operated level(s) using dynamic lateral cervical radiographs and graded according to the Daniel-Riew grading system (± CT when indicated) | 3, 6, and 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of cervical alignment | Measured by the Ishihara Cervical Lordosis Index on lateral cervical spine radiographs to evaluate the curvature of the neck. | Preoperatively, immediately postoperatively, and at 3, 6, and 12 months. |
| Change in segmental alignment at the operated level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| momen mohamed Roshdy, MBBCH | Contact | 00201129692785 | moemenroshdy2016@gmail.com | |
| Essam mohamed El-Morshidy, MD | Contact | 00201119343404 | esmorshidy@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Abdel-Hay El-Meshtawy | Assiut University, Faculty of Medicine, Orthopedic surgery and Traumatology. | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19949367 | Background | 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. | |
| Background | 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 | ||
| 12571477 |
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|
| traditional standalone cervical cage | Device | 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 |
|
Evaluation of the local kyphotic angle and disc angle measured by Cobb's method on radiographs |
| preoperatively and at 3, 6 and 12 months postoperatively |
| Restoration and maintenance of intervertebral disc height | Measured as the mean of anterior and posterior disc heights on lateral radiographs to assess space restoration. | Preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively |
| Cage subsidence | Defined as a reduction in disc height on serial radiographs, indicating the cage sinking into the vertebral endplates. | 3, 6, and 12 months postoperatively |
| Implant related complications | Assessment of cage migration or dislodgement on follow-up radiographs. | Each postoperative follow up visit (3, 6, and 12 months) |
| Pain intensity and functional outcome | Clinical assessment of neck and arm pain using the Visual Analog Scale (VAS) (0-10, lower is better) and functional disability using the Neck Disability Index (NDI) (0-100%, lower is better). | 3, 6, and 12 months postoperatively |
| Background |
| 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. |
| 22205113 | Background | 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. |
| 23429316 | Background | 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. |
| 20882376 | Background | 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. |
| 21369474 | Background | 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. |
| 16528190 | Background | 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. |
| 14609689 | Background | Samartzis D, Shen FH, Matthews DK, Yoon ST, Goldberg EJ, An HS. Comparison of allograft to autograft in multilevel anterior cervical discectomy and fusion with rigid plate fixation. Spine J. 2003 Nov-Dec;3(6):451-9. doi: 10.1016/s1529-9430(03)00173-6. |
| 1624483 | Background | Bohlman HH, Anderson PA. Anterior decompression and arthrodesis of the cervical spine: long-term motor improvement. Part I--Improvement in incomplete traumatic quadriparesis. J Bone Joint Surg Am. 1992 Jun;74(5):671-82. |
| 13599052 | Background | CLOWARD RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958 Nov;15(6):602-17. doi: 10.3171/jns.1958.15.6.0602. No abstract available. |
| 13539086 | Background | SMITH GW, ROBINSON RA. The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am. 1958 Jun;40-A(3):607-24. No abstract available. |