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Cervical Cage With ScrewNCT07430163

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

A study testing cervical cage with integrated screws and traditional standalone cervical cage in people with Cervical Cage With Screw and Cervical Degenerative Disc Disease, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
cervical cage with integrated screws and traditional standalone cervical cage
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
15 Mar 2026to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 9Show fewer
  • Osteoporosis or metabolic bone disease.
  • Pregnancy
  • Psychiatric illness or substance abuse that would compromise follow-up

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

momen mohamed Roshdy, MBBCH contact

00201129692785

moemenroshdy2016@gmail.com

Essam mohamed El-Morshidy, MD contact

00201119343404

esmorshidy@aun.edu.eg

About this study

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)

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

Read the 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

Being tested
cervical cage with integrated screws, traditional standalone cervical cage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cervical cage with integrated screwsDevice

    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

  • traditional standalone cervical cageDevice

    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

Study groups in NCT07430163
Study groupRoleWhat they receive
Screw-Integrated Cage GroupExperimental20 patients with cervical degenerative disc disease (CDDD) undergoing single or double-level ACDF using a cervical cage with integrated screw fixation.
Receives: Device: cervical cage with integrated screws
Traditional Cage GroupActive comparator20 patients with cervical degenerative disc disease (CDDD) undergoing single or double-level ACDF using a traditional standalone cervical cage
Receives: Device: traditional standalone cervical cage

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3, 6, and 12 months postoperatively

Secondary outcomes (6)
  1. Maintenance of cervical alignment

    Measured by the Ishihara Cervical Lordosis Index on lateral cervical spine radiographs to evaluate the curvature of the neck.

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

  2. Change in segmental alignment at the operated level

    Evaluation of the local kyphotic angle and disc angle measured by Cobb's method on radiographs

    Measured: preoperatively and at 3, 6 and 12 months postoperatively

  3. Restoration and maintenance of intervertebral disc height

    Measured as the mean of anterior and posterior disc heights on lateral radiographs to assess space restoration.

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

  4. Cage subsidence

    Defined as a reduction in disc height on serial radiographs, indicating the cage sinking into the vertebral endplates.

    Measured: 3, 6, and 12 months postoperatively

  5. Implant related complications

    Assessment of cage migration or dislodgement on follow-up radiographs.

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

  6. 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).

    Measured: 3, 6, and 12 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07430163
Sponsor's protocol ID
CDDD_Treatment
Status last verified
Feb 2026
First submitted
18 Feb 2026
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 16528190
  • 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.

    PubMed 14609689
  • 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.

    PubMed 1624483
  • 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.

    PubMed 13599052
  • 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.

    PubMed 13539086

Questions about this trial

What is this clinical trial studying?

A study testing cervical cage with integrated screws and traditional standalone cervical cage in people with Cervical Cage With Screw and Cervical Degenerative Disc Disease, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact momen mohamed Roshdy, MBBCH (00201129692785, moemenroshdy2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiological cervical interbody fusion. (time frame: 3, 6, and 12 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07430163, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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