Extensive Clinical Evidence

13 peer-reviewed clinical publications
Randomized controlled trial
Significant symptom improvement¹
High fusion rates: 98.1% at 2 years²
Low complication rate³

McCormack et al. Percutaneous posterior cervical fusion with the DTRAX Facet System for single-level radiculopathy: results in 60 patients. J Neurosurg Spine. 2013 Mar;18(3):245-54. doi: 10.3171/2012.12.SPINE12477. PubMed PMID: 23330952.

Siemionow et al. Clinical and Radiographic Results of Indirect Decompression and Posterior Cervical Fusion for Single-Level Cervical Radiculopathy Using an Expandable Implant with 2-Year Follow-Up. J Neurol Surg A Cent Eur Neurosurg. 2016 Nov;77(6):482-488. PubMed PMID: 27276119.

Siemionow KB, Glowka P, Blok RJ, Gillespy MC, Gundanna MI, Smith WD, Hyder Z, McCormack BM. Perioperative complications in patients treated with posterior cervical fusion and bilateral cages. J Craniovertebr Junction Spine.

Symptom Improvement

Significant improvement in symptoms as early as two weeks after surgery.1,2

McCormack et al. Percutaneous posterior cervical fusion with the DTRAX Facet System for single-level radiculopathy: results in 60 patients. J Neurosurg Spine. 2013 Mar;18(3):245-54. doi: 10.3171/2012.12.SPINE12477. PubMed PMID: 23330952.

Siemionow K, Janusz P, Phillips FM, Youssef JA, Isaacs R, Tyrakowski M, McCormack B. Clinical and Radiographic Results of Indirect Decompression and Posterior Cervical Fusion for Single-Level Cervical Radiculopathy Using an Expandable Implant with 2-Year Follow-Up. J Neurol Surg A Cent Eur Neurosurg. 2016 Nov;77(6):482-488. PubMed PMID: 27276119.

High Rate of Fusion

Evidence of Bridging Trabecular Bone

Siemionow K, Janusz P, Phillips FM, Youssef JA, Isaacs R, Tyrakowski M, McCormack B. Clinical and Radiographic Results of Indirect Decompression and Posterior Cervical Fusion for Single-Level Cervical Radiculopathy Using an Expandable Implant with 2-Year Follow-Up. J Neurol Surg A Cent Eur Neurosurg. 2016 Nov;77(6):482-488. PubMed PMID: 27276119.

Low Rate of Complications*

A retrospective, multicenter review of prospectively collected data performed at 11 centers.
Follow‑up evaluation included clinical status and pain scale (VAS – visual analog scale).
The procedure has a favorable overall complication profile, a short length of hospital stay (29 hours), and negligible blood loss.*
The overall complication rate for posterior cervical cages was 3.4%.
This complication rate compares favorably to the 12.33% overall complication profile reported for ACDF/arthroplasty.^1–13
Posterior cervical fusion with cages can be considered a safe alternative for patients undergoing cervical spine surgery.

* Compared to ACDF/arthroplasty, corpectomy, laminectomy, laminoplasty

Siemionow KB, Glowka P, Blok RJ, Gillespy MC, Gundanna MI, Smith WD, Hyder Z, McCormack BM. Perioperative complications in patients treated with posterior cervical fusion and bilateral cages. J Craniovertebr Junction Spine. 2017 Oct-Dec;8(4):342-349. doi: 10.4103/jcvjs.JCVJS_61_17. PubMed PMID: 29403247; PubMed Central PMCID: PMC5763592.

References

Q, Bi X, Ni B, Lu X, Chen J, Yang J, et al. Outcomes of three anterior decompression and fusion techniques in the treatment of three‑level cervical spondylosis. Eur Spine J 2011;20:1539‑44.
Lian XF, Xu JG, Zeng BF, Zhou W, Kong WQ, Hou TS. Noncontiguous anterior decompression and fusion for multilevel cervical spondylotic myelopathy: A prospective randomized control clinical study. Eur Spine J 2010;19:713‑9.
Uribe JS, Sangala JR, Duckworth EA, Vale FL. Comparison between anterior cervical discectomy fusion and cervical corpectomy fusion using titanium cages for reconstruction: Analysis of outcome and long‑term follow‑up. Eur Spine J 2009;18:654‑62.
Nirala AP, Husain M, Vatsal DK. A retrospective study of multiple interbody grafting and long segment strut grafting following multilevel anterior cervical decompression. Br J Neurosurg 2004;18:227‑32.
Song KJ, Lee KB, Song JH. Efficacy of multilevel anterior cervical discectomy and fusion versus corpectomy and fusion for multilevel cervical spondylotic myelopathy: A minimum 5‑year follow‑up study. Eur Spine J 2012;21:1551‑7. 20. Liu Y, Hou Y, Yang L, Chen H, Wang X, Wu X, et al. Comparison of 3 reconstructive techniques in the surgical management of multilevel cervical spondylotic myelopathy. Spine (Phila Pa 1976) 2012;37:E1450‑8.
Lin Q, Zhou X, Wang X, Cao P, Tsai N, Yuan W. A comparison of anterior cervical discectomy and corpectomy in patients with multilevel cervical spondylotic myelopathy. Eur Spine J 2012;21:474‑81.
Hwang SL, Lee KS, Su YF, Kuo TH, Lieu AS, Lin CL, et al. Anterior corpectomy with iliac bone fusion or discectomy with interbody titanium cage fusion for multilevel cervical degenerated disc disease. J Spinal Disord Tech 2007;20:565‑70.
Yonenobu K, Fuji T, Ono K, Okada K, Yamamoto T, Harada N. Choice of surgical treatment for multisegmental cervical spondylotic myelopathy. Spine (Phila Pa 1976) 1985;10:710‑6.
Bertalanffy H, Eggert HR. Complications of anterior cervical discectomy without fusion in 450 consecutive patients. Acta Neurochir (Wien) 1989;99:41‑50.
Burke JP, Gerszten PC, Welch WC. Iatrogenic vertebral artery injury during anterior cervical spine surgery. Spine J 2005;5:508‑14.
Emery SE, Bohlman HH, Bolesta MJ, Jones PK. Anterior cervical decompression and arthrodesis for the treatment of cervical spondylotic myelopathy. Two to seventeen‑year follow‑up. J Bone Joint Surg Am 1998;80:941‑51. Journal of Craniovertebral Junction and Spine / Volume 8 / Issue 4 / October-December 2017 349
Jamjoom ZA. Pharyngo‑cutaneous fistula following anterior cervical fusion. Br J Neurosurg 1997;11:69‑74.

Favourable Perioperative Metrics†

Posterior Fusion vs. Anterior Revision For Symptomatic Pseudarthrosis

† Compared to anterior revisions and posterior LMS screw and rod revisions.

Smith et al. Anterior Cervical Pseudarthrosis Treated with Bilateral Posterior Cervical Cages. Oper Neurosurg (Hagerstown). 2017 Jun 14. doi: 10.1093/ons/opx103. [Epub ahead of print] PubMed PMID: 28637309.

Siemionow, et al. Perioperative complications in patients treated with posterior cervical fusion and bilateral cages. J Craniovert Jun Spine 2017;8:342-9 doi: 10.4103/jcvjs.JCVJS_61_17

Carreon et al. Treatment of anterior cervical pseudoarthrosis: posterior fusion versus anterior revision. Spine J. 2006 Mar-Apr;6(2):154-6. Epub 2006 Jan 25. PubMed PMID: 16517386.

Elder BD, Sankey EW, Theodros D, et al. Successful anterior fusion following posterior cervical fusion for revision of anterior cervical discectomy and fusion pseudarthrosis. J Clin Neurosci. 2016;24:57-62. doi: 10.1016/j.jocn.2015.07.019.

Independent Prospective Randomized Study

PCF with Cages vs. Traction Single Level Cervical Radiculopathy 80 Patients @ 1-year follow-up

80 patients randomized into two groups—a surgical group in which patients were given posterior cervical fusion with cages and a traction group in which patients were treated conservatively with mechanical cervical tractions.
Visual analog scale for arm and neck, Neck Disability Index, and—Short Form-36 (SF-36) questionnaires administered preoperatively and after treatment up to 12 months.
Posterior cervical fusion with cages is a safe and effective procedure to treat single-level cervical radiculopathy.

Foraminal Expansion & Nerve Root Decompression

Radiographic analysis of 43 subjects enrolled in a prospective, multi-center study.
CT scans were obtained at baseline and 6- and 12-months after cervical fusion using bilateral posterior cervical cages.
Cervical cages placed bilaterally in the facet joints from a posterior approach significantly increase foraminal area.
Foraminal height, area, theoretical area, and inferior diagonal without implant (DISI) were significantly greater following implant placement.

Siemionow K, Janusz P, Glowka P. Cervical cages placed bilaterally in the facet joints from a posterior approach significantly increase foraminal area. Eur Spine J. 2016 Jul;25(7):2279-85. doi: 10.1007/s00586-016-4430-7. Epub 2016 Feb 11. PubMed PMID: 26869077.

Sagittal Balance

Posterior Cervical Fusion with Cages does not significantly change cervical alignment.

McCormack BM, Bundoc RC, Ver MR, Ignacio JM, Berven SH, Eyster EF. Percutaneous posterior cervical fusion with the DTRAX Facet System for single-level radiculopathy: results in 60 patients. J Neurosurg Spine. 2013 Mar;18(3):245-54. doi: 10.3171/2012.12.SPINE12477. Epub 2013 Jan 18. PubMed PMID: 23330952.

As with all medical devices, there are risks and considerations to device use. Please refer to the device labeling for a full discussion of potential risks, contraindications, warnings, precautions, and instructions for use.

The information presented on this website is intended only as a brief summary for visitor convenience. Not all products or indications are cleared in every country and may be subject to further local variations. For specific product information, you should always consult the local product documentation. For advice on medical issues, you should always consult your local medical practitioner.