Porous titanium cervical interbody fusion device in the treatment of degenerative cervical radiculopathy; 1-year results of a prospective controlled trial


      Background context

      Anterior cervical discectomy with an interbody cage (ACDF) to obtain fusion is a common procedure in cervical spine surgery. Presently, polyetheretherketone (PEEK) with (auto) graft is frequently used for interbody fusion although alternative implant technology like 3-D printing titanium has been introduced recently.


      Reporting the clinical and quantitative radiological outcome of a prospective cohort of 3-D printed porous titanium implants.

      Study design/setting

      Prospective study of patients with single level ACDF using 3-D printed porous titanium cervical implants. These data were compared with 48 patients from the PEEK with autograft group of the previously performed CAncellous Structured Ceramic Arthrodesis DEvice trial.

      Patient sample

      Fourty-nine patients were included.

      Outcome measures

      Neck disability index (NDI), visual analog scale (VAS), self-reported perceived recovery, and fusion status.


      The clinical outcomes and fusion rates were documented at 3, 6, and 12 months. Dynamic X-rays were analyzed to determine range of motion (ROM) of the operated level. Fusion was defined as rotation ≤4° and ≤1.25 mm translation on flexion-extension films.


      The mean NDI improved from 41.2 preoperatively to 19.4 at 12 months postoperatively. Both VAS arm and VAS neck improved significantly after surgery and 77.1% of the patients reported complete or nearly complete recovery at 12 months. The mean ROM of the affected disc level decreased from 8.7° (range 2.6–21.4) before surgery to 1.6° (0.0–4.6°) after 12 months. The fusion rate at 3, 6, and 12 months was 84%, 89%, and 91% respectively, compared with 67%, 72%, and 90%, in the PEEK group.


      3-D printed porous titanium cervical implants resulted in significant clinical improvement after surgery. The fusion rate of porous titanium compared with PEEK with autograft at 12 months was similar, although porous titanium resulted in faster consolidation. In addition, one level anterior cervical fusion can be successfully achieved without additional plating.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to The Spine Journal
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Cloward RB
        The anterior approach for removal of ruptured cervical disks.
        J Neurosurg. 1958; 15: 602-617
        • 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; 40-A: 607-624
        • Barlocher CB
        • Barth A
        • Krauss JK
        • Binggeli R
        • Seiler RW
        Comparative evaluation of microdiscectomy only, autograft fusion, polymethylmethacrylate interposition, and threaded titanium cage fusion for treatment of single-level cervical disc disease: a prospective randomized study in 125 patients.
        Neurosurg Focus. 2002; 12: E4
        • Jacobs W
        • Willems PC
        • Kruyt M
        • van LJ
        • Anderson PG
        • Pavlov P
        • et al.
        Systematic review of anterior interbody fusion techniques for single- and double-level cervical degenerative disc disease.
        Spine (Phila Pa 1976). 2011; 36: E950-E960
        • Nandoe Tewarie RD
        • Bartels RH
        • Peul WC
        Long-term outcome after anterior cervical discectomy without fusion.
        Eur Spine J. 2007; 16: 1411-1416
        • Hee HT
        • Kundnani V
        Rationale for use of polyetheretherketone polymer interbody cage device in cervical spine surgery.
        Spine J. 2010; 10: 66-69
        • Celik SE
        • Kara A
        • Celik S
        A comparison of changes over time in cervical foraminal height after tricortical iliac graft or polyetheretherketone cage placement following anterior discectomy.
        J Neurosurg Spine. 2007; 6: 10-16
        • Kulkarni AG
        • Hee HT
        • Wong HK
        Solis cage (PEEK) for anterior cervical fusion: preliminary radiological results with emphasis on fusion and subsidence.
        Spine J. 2007; 7: 205-209
        • Lied B
        • Roenning PA
        • Sundseth J
        • Helseth E
        Anterior cervical discectomy with fusion in patients with cervical disc degeneration: a prospective outcome study of 258 patients (181 fused with autologous bone graft and 77 fused with a PEEK cage).
        BMC Surg. 2010; 10: 10
        • Park HW
        • Lee JK
        • Moon SJ
        • Seo SK
        • Lee JH
        • Kim SH
        The efficacy of the synthetic interbody cage and Grafton for anterior cervical fusion.
        Spine (Phila Pa 1976). 2009; 34: E591-E595
        • Chau AM
        • Mobbs RJ
        Bone graft substitutes in anterior cervical discectomy and fusion.
        Eur Spine J. 2009; 18: 449-464
        • Olivares-Navarrete R
        • Gittens RA
        • Schneider JM
        • Hyzy SL
        • Haithcock DA
        • Ullrich PF
        • et al.
        Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic protein production on titanium alloy substrates than on poly-ether-ether-ketone.
        Spine J. 2012; 12: 265-272
        • Arts MP
        • Wolfs JFC
        • Corbin TP
        Porous silicon nitride spacers versus PEEK cages for anterior cervical discectomy and fusion: clinical and radiological results of a single-blinded randomized controlled trial.
        Eur Spine J. 2017; 26: 2372-2379
        • Heary RF
        • Parvathreddy N
        • Sampath S
        • Agarwal N
        Elastic modulus in the selection of interbody implants.
        J Spine Surg. 2017; 3: 163-167
        • Fukuda A
        • Takemoto M
        • Saito T
        • Fujibayashi S
        • Neo M
        • Yamaguchi S
        • et al.
        Bone bonding bioactivity of Ti metal and Ti-Zr-Nb-Ta alloys with Ca ions incorporated on their surfaces by simple chemical and heat treatments.
        Acta Biomater. 2011; 7: 1379-1386
        • Wu SH
        • Li Y
        • Zhang YQ
        • Li XK
        • Yuan CF
        • Hao YL
        • et al.
        Porous titanium-6 aluminum-4 vanadium cage has better osseointegration and less micromotion than a poly-ether-ether-ketone cage in sheep vertebral fusion.
        Artif Organs. 2013; 37: E191-E201
        • Arts MP
        • Wolfs JF
        • Corbin TP
        The CASCADE trial: effectiveness of ceramic versus PEEK cages for anterior cervical discectomy with interbody fusion; protocol of a blinded randomized controlled trial.
        BMC Musculoskelet Disord. 2013; 14: 244
        • Blackwelder WC
        "Proving the null hypothesis" in clinical trials.
        Control Clin Trials. 1982; 3: 345-353
        • Carreon LY
        • Glassman SD
        • Campbell MJ
        • Anderson PA
        Neck disability index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion.
        Spine J. 2010; 10: 469-474
        • Peolsson A
        Investigation of clinically important benefit of anterior cervical decompression and fusion.
        Eur Spine J. 2007; 16: 507-514
        • Vernon H
        • Mior S
        The neck disability index: a study of reliability and validity.
        J Manipulative Physiol Ther. 1991; 14: 409-415
        • Vos CJ
        • Verhagen AP
        • Koes BW
        Reliability and responsiveness of the Dutch version of the neck disability index in patients with acute neck pain in general practice.
        Eur Spine J. 2006; 15: 1729-1736
        • Collins SL
        • Moore RA
        • McQuay HJ
        The visual analogue pain intensity scale: what is moderate pain in millimetres.
        Pain. 1997; 72: 95-97
        • Bombardier C
        Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations.
        Spine (Phila Pa 1976). 2000; 25: 3100-3103
        • Brazier JE
        • Harper R
        • Jones NM
        • O'Cathain A
        • Thomas KJ
        • Usherwood T
        • et al.
        Validating the SF-36 health survey questionnaire: new outcome measure for primary care.
        BMJ. 1992; 305: 160-164
        • Ware Jr., JE
        • Sherbourne CD
        The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.
        Med Care. 1992; 30: 473-483
        • Lee C
        • Dorcil J
        • Radomisli TE
        Nonunion of the spine: a review.
        Clin Orthop Relat Res. 2004; : 71-75
        • Burkus JK
        • Foley K
        • Haid RW
        • LeHuec JC
        Surgical interbody research group–radiographic assessment of interbody fusion devices: fusion criteria for anterior lumbar interbody surgery.
        Neurosurg Focus. 2001; 10: E11
        • Ghiselli G
        • Wharton N
        • Hipp JA
        • Wong DA
        • Jatana S
        Prospective analysis of imaging prediction of pseudarthrosis after anterior cervical discectomy and fusion: computed tomography versus flexion-extension motion analysis with intraoperative correlation.
        Spine (Phila Pa 1976). 2011; 36: 463-468
        • Cheung ZB
        • Gidumal S
        • White S
        • Shin J
        • Phan K
        • Osman N
        • et al.
        Comparison of anterior cervical discectomy and fusion with a stand-alone interbody cage versus a conventional cage-plate technique: a systematic review and meta-analysis.
        Global Spine J. 2019; 9: 446-455