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

NCT07430163 | Not Yet Recruiting DMC

• 1 other identifier: CDDD_Treatment
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cervical Cage With Screw; Cervical Degenerative Disc Disease; Anterior Cervical Discectomy and Fusion (ACDF)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Maintenance of cervical alignment

  Preoperatively, immediately postoperatively, and at 3, 6, and 12 months.

• Change in segmental alignment at the operated level

  preoperatively and at 3, 6 and 12 months postoperatively

• Restoration and maintenance of intervertebral disc height

  Preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively

• Cage subsidence

  3, 6, and 12 months postoperatively

• Implant related complications

  Each postoperative follow up visit (3, 6, and 12 months)

Study Arms (2)

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.

Device: cervical cage with integrated screws

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

Device: traditional standalone cervical cage

Interventions

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

Screw-Integrated Cage Group

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

Traditional Cage Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Song KJ, Taghavi CE, Hsu MS, Lee KB, Kim GH, Song JH. Radiographic changes at the operated level after ACDF with cage alone versus plate fixation. Spine. 2009;34(26):2886- 2890.

  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

  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.

  PMID: 12571477 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.

  PMID: 22205113 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.

  PMID: 23429316 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.

  PMID: 20882376 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.

  PMID: 21369474 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.

  PMID: 16528190 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.

  PMID: 14609689 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.

  PMID: 1624483 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.

  PMID: 13599052 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.

  PMID: 13539086 BACKGROUND

Study Officials

• Mohamed Abdel-Hay El-Meshtawy

  Assiut University, Faculty of Medicine, Orthopedic surgery and Traumatology.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

momen mohamed Roshdy, MBBCH

CONTACT

00201129692785; moemenroshdy2016@gmail.com

Essam mohamed El-Morshidy, MD

CONTACT

00201119343404; esmorshidy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Orthopedic Surgery and Traumatology

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02