Carbon Fiber-Reinforced PolyEtherEtherKetone (CFR-PEEK) Instrumentation in Degenerative Disease of Lumbar Spine: A Pilot Study

Author:

Ghermandi Riccardo1,Tosini Giovanni1ORCID,Lorenzi Alberto2,Griffoni Cristiana1ORCID,La Barbera Luigi34ORCID,Girolami Marco1,Pipola Valerio1,Barbanti Brodano Giovanni1,Bandiera Stefano1,Terzi Silvia1,Tedesco Giuseppe1,Evangelisti Gisberto1,Monetta Annalisa1,Noli Luigi Emanuele1,Falzetti Luigi1,Gasbarrini Alessandro1

Affiliation:

1. Department of Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy

2. Ortopedia e Traumatologia 3 ad Indirizzo Chirurgia Vertebrale, AOU Città della Salute e della Scienza (Presidio CTO), 10126 Torino, Italy

3. Laboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering “G. Natta”, Politecnico di Milano, 20133 Milano, Italy

4. IRCCS Istituto Ortopedico Galeazzi, 20157 Milano, Italy

Abstract

CFR-PEEK is gaining popularity in spinal oncological applications due to its reduction of imaging artifacts and radiation scattering compared with titanium, which allows for better oncological follow-up and efficacy of radiotherapy. We evaluated the use of these materials for the treatment of lumbar degenerative diseases (DDs) and considered the biomechanical potential of the carbon fiber in relation to its modulus of elasticity being similar to that of bone. Twenty-eight patients with DDs were treated using CRF-PEEK instrumentation. The clinical and radiographic outcomes were collected at a 12-month FU. Spinal fusion was evaluated in the CT scans using Brantigan scores, while the clinical outcomes were evaluated using VAS, SF-12, and EQ-5D scores. Out of the patients evaluated at the 12-month FU, 89% showed complete or almost certain fusion (Brantigan score D and E) and presented a significant improvement in all clinical parameters; the patients also presented VAS scores ranging from 6.81 ± 2.01 to 0.85 ± 1.32, EQ-5D scores ranging from 53.4 ± 19.3 to 85.0 ± 13.7, SF-12 physical component scores (PCSs) ranging from 29.35 ± 7.04 to 51.36 ± 9.75, and SF-12 mental component scores (MCSs) ranging from 39.89 ± 11.70 to 53.24 ± 9.24. No mechanical complications related to the implant were detected, and the patients reported a better tolerance of the instrumentation compared with titanium. No other series of patients affected by DD that was stabilized using carbon fiber implants have been reported in the literature. The results of this pilot study indicate the efficacy and safety of these implants and support their use also for spinal degenerative diseases.

Funder

Italian Ministry of Health

Publisher

MDPI AG

Subject

Bioengineering

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