Carbon Fiber Reinforced Hybrid Polyaryl-Ether-Ether-Ketone (PEEK) Spinal Fixation System: Technical Features and Preliminary Clinical Trial

Overview

Journal Indian J Orthop

Publisher Springer Nature

Specialty Orthopedics

Date 2024 Dec 30

PMID 39735879

Authors

Eyal Behrbalk

Uri Ofir

David Maman

Itzhak Engel

Yoram Folman

Affiliations

Soon will be listed here.

Abstract

Objective: To present the clinical result of spinal fixation system made entirely of Carbon-Fiber-Reinforced (CFR)-Hybrid Polyaryl-Ether-Ether-Ketone (PEEK).

Summary Of Background Data: Fusion surgery has been used to treat chronic low back pain caused by degenerative disk disease (DDD). The traditional pedicle screw system made of titanium, though biocompatible, can lead to complications, such as stress shielding and implant failure.

Methods: Fifty-two patients with one-level degenerative disc disease, with or without spinal stenosis, were treated with a stand-alone novel pedicular screw system (PSS) made entirely of CFR-PEEK composite biomaterial. Forty-six were followed for 24 months. Changes in pain and disability were evaluated using a 0-10-point visual analog scale (VAS) and a 0-90 (after omitting the question related to sex life) Oswestry Disability Index (ODI), respectively. Imaging evaluations of fusion were performed with standard and dynamic radiographs.

Results: Mean age was 58.4 ± 12.7 years. The mean operating time was 114.9 ± 22.7 min; X-ray exposure was 38.5 ± 18.1 s. No operative problems or complications were encountered. Three patients were lost to follow-up and three patients were re-operated. Forty-six patients completed follow-up of 24 months; the mean VAS was 6.49 points for lower back pain and 6.54 for leg pain, and the mean ODI by 41.6. No screw breakage or loosening was reported. Radiological consolidation was observed in all patients within 12 months. No clinical symptoms or radiological signs of adjacent degenerative disc disease were observed up to 24 months.

Conclusions: The all CFR-PEEK PSS is user friendly, safe, and compatible with modern imaging techniques. Its mechanical strength lessens the risk of implant failure, while its bone matching elastic modules seem to contribute in the short term to fusion, and in the long term to potential prevention of adjacent disk disease.

References

Boriani S, Tedesco G, Ming L, Ghermandi R, Amichetti M, Fossati P . Carbon-fiber-reinforced PEEK fixation system in the treatment of spine tumors: a preliminary report. Eur Spine J. 2017; 27(4):874-881. DOI: 10.1007/s00586-017-5258-5. View

Prudhomme M, Barrios C, Rouch P, Charles Y, Steib J, Skalli W . Clinical Outcomes and Complications After Pedicle-anchored Dynamic or Hybrid Lumbar Spine Stabilization: A Systematic Literature Review. J Spinal Disord Tech. 2014; 28(8):E439-48. DOI: 10.1097/BSD.0000000000000092. View

Highsmith J, Tumialan L, Rodts Jr G . Flexible rods and the case for dynamic stabilization. Neurosurg Focus. 2007; 22(1):E11. DOI: 10.3171/foc.2007.22.1.11. View

Brantigan J, Steffee A, Lewis M, Quinn L, Persenaire J . Lumbar interbody fusion using the Brantigan I/F cage for posterior lumbar interbody fusion and the variable pedicle screw placement system: two-year results from a Food and Drug Administration investigational device exemption clinical trial. Spine (Phila Pa 1976). 2000; 25(11):1437-46. DOI: 10.1097/00007632-200006010-00017. View

Martin B, Mirza S, Comstock B, Gray D, Kreuter W, Deyo R . Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures. Spine (Phila Pa 1976). 2007; 32(3):382-7. DOI: 10.1097/01.brs.0000254104.55716.46. View

De Iure F, Bosco G, Cappuccio M, Paderni S, Amendola L . Posterior lumbar fusion by peek rods in degenerative spine: preliminary report on 30 cases. Eur Spine J. 2012; 21 Suppl 1:S50-4. PMC: 3325394. DOI: 10.1007/s00586-012-2219-x. View

Turner J, Paller D, Murrell C . The mechanical effect of commercially pure titanium and polyetheretherketone rods on spinal implants at the operative and adjacent levels. Spine (Phila Pa 1976). 2010; 35(21):E1076-82. DOI: 10.1097/BRS.0b013e3181df1b85. View

Martin B, Mirza S, Comstock B, Gray D, Kreuter W, Deyo R . Are lumbar spine reoperation rates falling with greater use of fusion surgery and new surgical technology?. Spine (Phila Pa 1976). 2007; 32(19):2119-26. DOI: 10.1097/BRS.0b013e318145a56a. View

Kim K, Lee S, Lee Y, Bae S, Suk K . Clinical outcomes of 3 fusion methods through the posterior approach in the lumbar spine. Spine (Phila Pa 1976). 2006; 31(12):1351-7. DOI: 10.1097/01.brs.0000218635.14571.55. View

10.

Uri O, Folman Y, Laufer G, Behrbalk E . A Novel Spine Fixation System Made Entirely of Carbon-Fiber-Reinforced PEEK Composite: An In Vitro Mechanical Evaluation. Adv Orthop. 2020; 2020:4796136. PMC: 7301173. DOI: 10.1155/2020/4796136. View

11.

Gioe T, Killeen K, Grimm K, Mehle S, Scheltema K . Why are total knee replacements revised?: analysis of early revision in a community knee implant registry. Clin Orthop Relat Res. 2004; (428):100-6. View

12.

Asher M, Carson W, Hardacker J, Lark R, Lai S . The effect of arthrodesis, implant stiffness, and time on the canine lumbar spine. J Spinal Disord Tech. 2007; 20(8):549-59. DOI: 10.1097/BSD.0b013e31804c98e5. View

13.

Zotti M, Brumby-Rendell O, McDonald B, Fisher T, Tsimiklis C, Yoon W . The outcome of pedicle screw instrumentation removal for ongoing low back pain following posterolateral lumbar fusion. J Spine Surg. 2016; 1(1):50-6. PMC: 5039860. DOI: 10.3978/j.issn.2414-469X.2015.08.02. View

14.

Carragee E, Cheng I . Minimum acceptable outcomes after lumbar spinal fusion. Spine J. 2010; 10(4):313-20. DOI: 10.1016/j.spinee.2010.02.001. View

15.

Ponnappan R, Serhan H, Zarda B, Patel R, Albert T, Vaccaro A . Biomechanical evaluation and comparison of polyetheretherketone rod system to traditional titanium rod fixation. Spine J. 2008; 9(3):263-7. DOI: 10.1016/j.spinee.2008.08.002. View

16.

Matsuzaki H, Tokuhashi Y, Matsumoto F, Hoshino M, Kiuchi T, Toriyama S . Problems and solutions of pedicle screw plate fixation of lumbar spine. Spine (Phila Pa 1976). 1990; 15(11):1159-65. DOI: 10.1097/00007632-199011010-00014. View

17.

Myers M, Casciani T, Whitbeck Jr M, Puzas J . Vertebral body osteopenia associated with posterolateral spine fusion in humans. Spine (Phila Pa 1976). 1996; 21(20):2368-71. DOI: 10.1097/00007632-199610150-00012. View

18.

Golish S, Mihalko W . Principles of biomechanics and biomaterials in orthopaedic surgery. J Bone Joint Surg Am. 2011; 93(2):207-12. DOI: 10.2106/00004623-201101190-00013. View

19.

Ringel F, Ryang Y, Kirschke J, Muller B, Wilkens J, Brodard J . Radiolucent Carbon Fiber-Reinforced Pedicle Screws for Treatment of Spinal Tumors: Advantages for Radiation Planning and Follow-Up Imaging. World Neurosurg. 2017; 105:294-301. DOI: 10.1016/j.wneu.2017.04.091. View

20.

Gertzbein S, Robbins S . Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990; 15(1):11-4. DOI: 10.1097/00007632-199001000-00004. View