bioengineering

Article
Carbon Fiber-Reinforced PolyEtherEtherKetone (CFR-PEEK)
Instrumentation in Degenerative Disease of Lumbar Spine: A
Pilot Study
Riccardo Ghermandi 1 , Giovanni Tosini 1, * , Alberto Lorenzi 2 , Cristiana Griffoni 1, * , Luigi La Barbera 3,4 ,
Marco Girolami 1 , Valerio Pipola 1 , Giovanni Barbanti Brodano 1 , Stefano Bandiera 1 , Silvia Terzi 1 ,
Giuseppe Tedesco 1 , Gisberto Evangelisti 1 , Annalisa Monetta 1 , Luigi Emanuele Noli 1 , Luigi Falzetti 1
and Alessandro Gasbarrini 1

1 Department of Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy;
[email protected] (R.G.); [email protected] (M.G.); [email protected] (V.P.);
[email protected] (G.B.B.); [email protected] (S.B.); [email protected] (S.T.);
[email protected] (G.T.); [email protected] (G.E.); [email protected] (A.M.);
[email protected] (L.F.); [email protected] (A.G.)
2 Ortopedia e Traumatologia 3 ad Indirizzo Chirurgia Vertebrale, AOU Città della Salute e della
Scienza (Presidio CTO), 10126 Torino, Italy; [email protected]
3 Laboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering
“G. Natta”, Politecnico di Milano, 20133 Milano, Italy; [email protected]
4 IRCCS Istituto Ortopedico Galeazzi, 20157 Milano, Italy
* Correspondence: [email protected] (G.T.); [email protected] (C.G.);
Tel.: +39-051-636-6130 (G.T. & C.G.)

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
Citation: Ghermandi, R.; Tosini, G.; follow-up and efficacy of radiotherapy. We evaluated the use of these materials for the treatment of
Lorenzi, A.; Griffoni, C.; La Barbera, lumbar degenerative diseases (DDs) and considered the biomechanical potential of the carbon fiber in
L.; Girolami, M.; Pipola, V.; Barbanti relation to its modulus of elasticity being similar to that of bone. Twenty-eight patients with DDs were
Brodano, G.; Bandiera, S.; Terzi, S.; treated using CRF-PEEK instrumentation. The clinical and radiographic outcomes were collected at a
et al. Carbon Fiber-Reinforced 12-month FU. Spinal fusion was evaluated in the CT scans using Brantigan scores, while the clinical
PolyEtherEtherKetone (CFR-PEEK)
outcomes were evaluated using VAS, SF-12, and EQ-5D scores. Out of the patients evaluated at the
Instrumentation in Degenerative
12-month FU, 89% showed complete or almost certain fusion (Brantigan score D and E) and presented
Disease of Lumbar Spine: A Pilot
a significant improvement in all clinical parameters; the patients also presented VAS scores ranging
Study. Bioengineering 2023, 10, 872.
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
https://doi.org/10.3390/
bioengineering10070872
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
Academic Editor: Aurélien
implant were detected, and the patients reported a better tolerance of the instrumentation compared
Courvoisier
with titanium. No other series of patients affected by DD that was stabilized using carbon fiber
Received: 12 June 2023 implants have been reported in the literature. The results of this pilot study indicate the efficacy and
Revised: 3 July 2023 safety of these implants and support their use also for spinal degenerative diseases.
Accepted: 18 July 2023
Published: 23 July 2023 Keywords: degenerative lumbar spine disease; carbon fiber; CRF-PEEK; spine fusion; spondylolis-
thesis

Copyright: © 2023 by the authors.

Licensee MDPI, Basel, Switzerland. 1. Introduction
This article is an open access article
distributed under the terms and
Over the last few decades, metal implants have become commonly used in spinal
conditions of the Creative Commons
surgery for the stabilization of the spinal column using pedicle screws and rods to treat
Attribution (CC BY) license (https://
different pathologies of the spine; these types of instrumentation have dramatically in-
creativecommons.org/licenses/by/ creased the union rate in spinal fusion. Spinal implants need to have good performance in
4.0/). biofunctionality and biocompatibility. Biofunctionality is concerned with the mechanical

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Bioengineering 2023, 10, 872 2 of 12

properties of alloys, as high yield strength, stiffness, and fatigue are required. Biocompati-
bility refers to the interaction of an alloy with the internal environment of the human body;
the integration of the implant with bone is relevant to reduce the possibility of device failure
or loosening. Due to its remarkable mechanical strength, high fatigue/corrosion resistance,
low density, high biocompatibility, and possibility to be contoured intraoperatively for a tai-
lored fit, titanium has become the metal of choice for spine surgery, replacing stainless steel
implants. Titanium and titanium alloys are also used in orthopedic surgery for components
of prostheses in total hip arthroplasty, total knee arthroplasty, and fracture fixation. More-
over, it is possible to enhance titanium’s properties by combining it with other elements
(i.e., Zr, O, Al) or by modifying its manufacturing process. However, metal implants also
have disadvantages, which include limited fatigue life, low wear resistance, a mismatch of
modulus elasticity between the metal and the bone, potential for debris generation, allergic
host response, and imaging artifacts in MRI, X-rays, and CT evaluations [1–3].
Over the last few years, glass fibers (GFs) and carbon fibers (CFs) have been largely
studied and used in the production of advanced polymer composites, i.e., glass fiber-
reinforced polymer (GFRP) and carbon fiber-reinforced polymer (CRFP) composites. In
particular, the main characteristics of CFs, such as their light weight, high stiffness, high
tensile strength, good fatigue resistance, good vibration damping, high-temperature sta-
bility, high chemical/corrosion endurance, good electro-magnetic properties, electrical
conductivity, X-ray permeability, and low coefficient of thermal expansion, have made
them very popular in various engineering applications, including aerospace, automobile
and marine transport, military, civil engineering, sporting goods, and medical application
(surgery and X-ray equipment, prostheses, tendon/ligament implants) [4]. Recently, carbon
fibers have been mixed with synthetic and natural fibers to obtain reinforced composite
materials in different areas [5].
Carbon fiber-reinforced (CRF) composite materials have also been developed to help
overcome some of the disadvantages of standard metallic implants. Their mechanical
properties depend on the carbon fibers’ amount, alignment, and length, and they are tuned
to match the qualities of human bone [6]. In particular, CFR-PEEK has been used to realize
many different types of orthopedic and spinal implants (e.g., plates, nails, pedicle screws,
spinal rods), and it has been gaining popularity in the spine and appendicular skeleton
oncologic applications because of the reduction of artifacts in imaging procedures (MRI
and CT) compared with titanium, allowing for more feasible tumor follow up, simpler
radiotherapy planning, and potentially greater safety and quality for radiation therapy [7,8].
The use of CFR-PEEK instrumentation (rods and pedicle screws) for the treatment
of primary and metastatic spinal tumors has been recently described in several clinical
studies [9–12], and it has been demonstrated that postoperative CT and MRI scans show
reduced artifacts in patients who received CFR-PEEK pedicle screws for the treatment of
spinal tumors when compared with standard titanium alloy implants [13].
Concerning the biomechanical literature, CFR-PEEK rods have been shown to have
tunable mechanical properties, particularly with respect to the bending and compressive
moduli and strength to parameters that are comparable or superior to those of cortical
bone [14]. CFR-PEEK can be used for semirigid stabilization, and it demonstrates bending
stiffness, yield and ultimate loads, and a fatigue strength that is comparable with or higher
than rigid titanium systems [15]; although the torsional stiffness and yield torque are
lower than titanium implants, they are suitable for withstanding the physiological loads.
Moreover, CFR-PEEK rods can provide effective primary stability, better kinematics, and
improved load-sharing compared with titanium implants [16]. CFR-PEEK pedicle screws
have been shown to have higher pullout strength [15] and comparable or higher resistance
to screw loosening than traditional implants [17,18], which is explained by the absence
of the mismatch between the mechanical properties of CFR-PEEK and the surrounding
bone, thus reducing the stresses and strains at the bone-implant interface. CFR-PEEK
also has good biocompatibility, enhanced osteogenic property, and bioactivity [19,20].
Radiolucency and CT/MRI artifact-free features may offer additional advantages over
 the mismatch between the mechanical properties of CFR-PEEK and the surrounding bone,
thus reducing the stresses and strains at the bone-implant interface. CFR-PEEK also has
good biocompatibility, enhanced osteogenic property, and bioactivity [19,20].
Radiolucency and CT/MRI artifact-free features may offer additional advantages over
Bioengineering 2023, 10, 872 traditional spine fixation systems that are constructed using metal alloys [21]. These 3 of 12
biomechanical properties have prompted us to think that the use of CRF-PEEK could also
be advantageous for the stabilization of the spine in patients affected by degenerative
diseases.
traditional spine fixation systems that are constructed using metal alloys [21]. These
Recently, properties
biomechanical a study have investigated
prompted the use
us to of that
think CFR-PEEK
the use ofinstrumentation
CRF-PEEK couldfor alsothe
be
treatment of degenerative spinal disorders [22]. The authors analyzed
advantageous for the stabilization of the spine in patients affected by degenerative diseases. artifacts formation
at MRI assessment
Recently, a study and compared the
investigated titanium
use of and CRF-PEEK
CFR-PEEK instrumentation.
instrumentation for theCRF-PEEK
treatment
pedicle screws exhibited
of degenerative smaller[22].
spinal disorders artifact
The areas
authors onanalyzed
vertebralartifacts
body surfaces
formation and at their
MRI
surrounding
assessment and tissues, improving
compared the radiographic
titanium and CRF-PEEK assessability and providing
instrumentation. CRF-PEEK a diagnostic
pedicle
benefit.
screws exhibited smaller artifact areas on vertebral body surfaces and their surrounding
A few
tissues, biomechanical
improving comparative
the radiographic studies have
assessability and demonstrated the potential
providing a diagnostic of CFR-
benefit.
PEEKAfor enhancing the load-sharing on the anterior column
few biomechanical comparative studies have demonstrated the potential of CFR-and reducing the loads on
the
PEEKadjacent proximalthe
for enhancing discload-sharing
[23,24], but no onclinical studycolumn
the anterior has beenand
published
reducing yet. This
the paper
loads on
presents
the adjacenta case series ofdisc
proximal patients treated
[23,24], but with CRF-PEEK
no clinical study instrumentation
has been publishedfor theyet.
posterior
This
stabilization
paper presents of athe
casespine
seriesinofdegenerative
patients treated lumbar
withspine
CRF-PEEKdisease with the purpose
instrumentation for theof
assessing stabilization
posterior the fusion rate of and clinical
the spine in outcomes.
degenerative lumbar spine disease with the purpose
of assessing the fusion rate and clinical outcomes.
2. Materials and Methods
2. Materials and Methods
Patients who underwent lumbar interbody fusion with CFR-PEEK instrumentation
in ourPatients
institutionwhofromunderwent
Octoberlumbar
2015 tointerbody
November fusion
2021 with
were CFR-PEEK
enrolled in instrumentation
two prospective
in our institution from October 2015 to November
clinical studies, which was approved by the local ethics committee 2021 were enrolled inon two prospective
October 2014
(protocol number 0033475) and on July 2018 (protocol number 2014
clinical studies, which was approved by the local ethics committee on October (proto-
CE-AVEC:
col number 0033475) In
208/2018/Disp/IOR). andthe onfirst
July study,
2018 (protocol number®CE-AVEC:
the CarboClear 208/2018/Disp/IOR).
system (CarboFix Orthopedics,
In the firstIsrael)
study,was theused,
CarboClear ® system (CarboFix Orthopedics,
Herzliya, while in the second study, the BlackArmorHerzliya, Israel) AG,
® system (Icotec was
used, while in the second study, the BlackArmor ® system (Icotec AG, Altstaetten, Switzer-
Altstaetten, Switzerland) was used. Both implants had similar characteristics, with
land) wasscrews
polyaxial used. Both implants
and rods had similar
that were preformed characteristics,
in lordosis andwithhad
polyaxial
a 5.5–6.0screws and rods
mm diameter.
that were preformed in lordosis and had a 5.5–6.0 mm diameter.
Patients were included in the study following the signature of a study-specific consent Patients were included
in the study
form. Inclusionfollowing
criteriathe signature
were patients of aaged
study-specific
18 years or consent
more form. Inclusion
that were affectedcriteria
by
were patients aged 18 years or more that were affected by degenerative lumbar disease
degenerative lumbar disease or low-grade spondylolisthesis. The exclusion criteria were
or low-grade spondylolisthesis. The exclusion criteria were high-grade spondylolisthesis,
high-grade spondylolisthesis, oncologic or infectious disease, previous spinal
oncologic or infectious disease, previous spinal instrumentation, bone metabolic disease or
instrumentation, bone metabolic disease or use of osteoanabolic drugs, and obesity.
use of osteoanabolic drugs, and obesity.
The consecutive steps of the study are reported in a flow chart (Figure 1).
The consecutive steps of the study are reported in a flow chart (Figure 1).

Figure 1. Flow chart of the study.

All of the patients enrolled received a standard open PLIF/TLIF procedure with a
composite CFR-PEEK fixation system (CarboClear or BlackArmor) and combined PEEK
core/titanium-surfaced interbody cage (Concorde® ProTi 360◦ System, Depuy Synthes,
Palm Beach Garden, FL, USA, with the dimensions being 9 × 23 or 9 × 27 mm and the
height ranging from 7 to 15 mm). The spinal instrumentation with pedicle screws and rods
 follow up periods and were classified according to SAVES v2 [25].
Radiographic images and a CT scan at 12 months were used to determine the degree
of fusion and bone regeneration. Bone regeneration and the degree of fusion were
determined by an independent radiologist using a CT scan analysis. Bone regeneration
Bioengineering 2023, 10, 872 was identified as the presence of a continuous trabecular bone bridge along with the4 of
lack
12
of radiolucency, as assessed by the diagnostic imaging (CT scan), and it was evaluated by
using Brantigan–Steffee classification, which assesses spinal fusion from grade A
(pseudoarthrosis) to grade E (certain fusion) [26]. Spinal fusion was considered successful
is represented in Figure 2. While screws and rods provide primary stability to the spine, a
if the scores were D and E.
bone graft was added to achieve a stable spinal fusion.

Figure 2. Image
Figure 2. Image of
of aa section
section of
of the
the spine
spine where
where the
the pedicle
pedicle screws
screws and
and bars
bars connecting
connecting the
the screws
screws
have been
have been inserted
inserted to
to stabilize
stabilize the
the spine.
spine.

Post-op
Statistical CT scans and standard radiograms before discharge were collected. Patients
Analysis
were evaluated at 6 and 12 months. Patient-reported outcomes (VAS, SF-12, and EQ-5D
No sample size calculation was performed because of the study s design (pilot
scores) were also collected at baseline and at a 12-month follow up. The authors asked
study). Considering the small number of patients treated, no specific statistical analyses
the patients if they felt the presence of the spinal instrumentation and if this presence was
have been carried out. A descriptive statistical analysis has been provided for the clinical
particularly relevant in association with a change in weather or temperature. The possible
scores (VAS, ODI, and EQ-5D) and for the fusion assessment.
answers to the question: “when you feel the presence of the implants in your spine?” were
scored as follows: 1 = never; 2 = only during weather/temperature change; 3 = occasionally;
4 = always. Adverse events were collected in the intra-operative, post-operative, and follow
up periods and were classified according to SAVES v2 [25].
Radiographic images and a CT scan at 12 months were used to determine the degree
of fusion and bone regeneration. Bone regeneration and the degree of fusion were deter-
mined by an independent radiologist using a CT scan analysis. Bone regeneration was
identified as the presence of a continuous trabecular bone bridge along with the lack of
radiolucency, as assessed by the diagnostic imaging (CT scan), and it was evaluated by
using Brantigan–Steffee classification, which assesses spinal fusion from grade A (pseu-
doarthrosis) to grade E (certain fusion) [26]. Spinal fusion was considered successful if the
scores were D and E.

Statistical Analysis
No sample size calculation was performed because of the study’s design (pilot study).
Considering the small number of patients treated, no specific statistical analyses have been
carried out. A descriptive statistical analysis has been provided for the clinical scores (VAS,
ODI, and EQ-5D) and for the fusion assessment.
Results are presented as the number (n), mean ± standard deviation, and percentage,
as appropriate. After having verified a normal distribution and homogeneity of variance, a
two-way ANOVA test was performed to detect the changes from baseline to the follow-up
scores. The level of statistical significance was set at p < 0.05. GraphPad Prism software
was used.
Bioengineering 2023, 10, 872 5 of 12

3. Results
Twenty-eight patients were enrolled following the informed consent approval and
signature. The demographic and clinical data are reported in Table 1. All of the patients had
a diagnosis of disc degenerative disease and underwent a transforaminal lumbar interbody
fusion (TLIF) procedure with CRF-PEEK rods, pedicle screws, and carbon fiber cages. In
three cases, the procedure was performed using minimally invasive surgery. Nineteen
patients (67.9%) had only one instrumented level, and the most frequently treated level was
L5 (41.8%). Six patients (21.4%) were previously surgically treated without instrumentation
(herniectomy or interspinous device). The mean follow-up period was 43 months. One
intra-operative adverse event was observed in the form of L5 screw malpositioning; no
other adverse events were collected.

Table 1. Demographic and clinical data.

Study Sample
(Total Number = 28 Patients)
Age, year median (range) 48 (20–75)
Sex, n (%)
Male 14 (50.0)
Female 14 (50.0)
Number of instrumented levels a , n (%)
1 19 (67.9)
2 7 (25)
3 2 (7.1)
Levels instrumented b , n (%)
L2 1 (1.5)
L3 3 (4.5)
L4 17 (25.4)
L5 28 (41.8)
S1 17 (25.4)
Total number of instrumented levels 67
Previous non-instrumented surgery c , n (%) 6 (21.4)
a indicates how many levels have been instrumented with pedicle screws in different patients. b indicates which

vertebral levels have been instrumented with pedicle screws in different patients. c indicates how many patients
in the study population had previous spinal surgery without instrumentation.

Spinal fusion was assessed in the CT scan examinations performed 12 months after
surgery and was evaluated using the Brantigan–Steffee classification, as reported in Table 2.
A total of 24 cases (89% of patients) had the radiographic fusion scored as D or E, thus
being considered successful.
Moreover, at 12 months follow-up, all clinical outcomes improved as reported in
Figure 1. The VAS score decreased from 6.81 ± 2.01 to 0.85 ± 1.32 (Figure 1), the EQ-5D
score increased from 53.4 ± 19.3 to 85.0 ± 13.7 (Figure 1), the SF-12 physical component
score (PCS) increased from 29.35 ± 7.04 to 51.36 ± 9.75 (Figure 1), and the SF-12 mental
component score (MCS) increased from 39.89 ± 11.70 to 53.24 ± 9.24 (Figure 3).
Nine patients had the degeneration grade of the proximal adjacent intervertebral
disc evaluated using MRI before and after surgery by the Pfirrmann score. In eight cases,
no change was observed in the Pfirrmann grade, whereas in two cases, the Pfirrmann
grade increased.
Finally, we asked patients to report about their perception of the presence of spinal
instrumentation, particularly in correlation with the weather and changes in temperature.
The results of the survery are reported in Table 3. A total of 71% of patients never felt the
presence of spinal instrumentation and 21% of patients only felt discomfort when there
were changes in weather and temperature. Most patients with titanium instrumentation
complain of some discomfort due to its presence, which is increased when there are
climatic changes.
Bioengineering 2023, 10, 872 6 of 12

Bioengineering 2023, 10, 872 6 of 12

Table 2. Brantigan–Steffee classification of spinal fusion.

Table 2. Brantigan–Steffee classification of spinal fusion. Number
Classification Description
of Cases
Classification Description
Pseudoarthrosis, collapse Numberslip,
of construct, loss of disc height, vertebral of Cases
A- Obvious radiographic pseudoarthrosis 0
broken screw,collapse
Pseudoarthrosis, displacement of the cage,
of construct, loss ofresorption
disc of bone graft
A- Obvious radiographic Significant
height, resorption
vertebral of bone
slip, broken screw,graft, major lucency,
displacement of theor gap visible in 0the
B- Probable pseudoarthrosis
pseudoarthrosis 0
cage, resorption fusion
of bonearea
graft
>2 mm
A small lucency
Significant resorptionor gap may graft,
of bone be visible
majorwith at least
lucency, orhalf of the graft area
C- Radiographic status uncertain 4
B- Probable pseudoarthrosis showing no lucency between the graft
gap visible in the fusion area > 2 mm bone and the vertebral bone0
Bone bridges the entire fusion area with at least the density originally
A small lucency or gap may be visible with at least half
D- Probable radiographic fusion achieved at surgery. There should be no lucency between the graft bone 4
C- Radiographic status uncertain of the graft area showing no lucency between the graft 4
and the vertebral
bone and the vertebral bone bone.
The bone in the fusion area is more dense and more mature than origi-
Bone bridges the entire fusion area with at least the
nally achieved at surgery; there is no interface between the donor bone
density originally achieved at surgery. There should be
E- D- Radiographic fusion
Probable radiographic fusion and the vertebral bone: a sclerotic line between the graft bone and the 4 20
no lucency between the graft bone and the vertebral
vertebral bone indicates solid
bone. fusion. Other indicators of solid fusion are
fusion at the facet joints and anterior progression of the graft in the disc.
The bone in the fusion area is more dense and more
mature than originally achieved at surgery; there is no
Moreover, at 12 months
interface betweenfollow-up, all clinical
the donor bone and theoutcomes
vertebral improved as reported in Fig-
E- Radiographic fusion ure 1. The VAS score
bone: decreased
a sclerotic line from 6.81the± graft
between 2.01 to 0.85
bone ± 1.32
and the (Figure 1), the20EQ-5D score
increased from 53.4 bone
vertebral ± 19.3 to 85.0solid
indicates ± 13.7 (Figure
fusion. Other1), the SF-12
indicators of physical component score
solid
(PCS) increased fusion
from are fusion
29.35 ± 7.04 at
tothe facet
51.36 ± joints and anterior
9.75 (Figure 1), and the SF-12 mental compo-
progression
nent score (MCS) increased fromof39.89
the graft in the
± 11.70 todisc.
53.24 ± 9.24 (Figure 3).

VAS (a) EQ-5D (b)

10 120

8 100 ***

6 80

4 60
***
2 40

0 20
Baseline 12 months FU
-2 0
Baseline 12 months FU

PCS12 (c) MCS12 (d)

70 70
*** ***
60 60
50 50
40 40
30 30
20 20
10 10
0 0
Baseline 12 months FU Baseline 12 months FU

(a)Plot
Figure3.3.(a)
Figure Plotofofthe
thevisual
visualanalog
analogscalescale(VAS)
(VAS)score
scoreas
asevaluated
evaluatedpreoperatively
preoperativelyand
andatat12
12months
months
follow-up. The black
follow-up. The black asterisks show a significant difference between post-operative and preoperative
show a significant difference between post-operative and preopera-
tive values
values p <p0.0005).
(***(*** < 0.0005).(b)(b) Plotofofthe
Plot theEQ-5D
EQ-5Dscore
scoreasasevaluated
evaluated preoperatively
preoperatively and atat 12
12 months
months
follow-up. The black
follow-up. The black asterisks show a significant difference between post-operative and preopera-
show a significant difference between post-operative and preoperative
tive values
values (***(***
p <p0.0005).
< 0.0005). (c,d)
(c,d) Plotofofthe
Plot theSF12
SF12physical
physicalcomponent
component (PCS12)
(PCS12) and
and mental
mental component
component
(MCS12) as evaluated preoperatively and at 12 months follow-up. The
(MCS12) as evaluated preoperatively and at 12 months follow-up. The black asterisks black asterisks showshow
a sig-a
nificant difference between post-operative and preoperative values (*** p < 0.0005).
significant difference between post-operative and preoperative values (*** p < 0.0005).

Nine patients had the degeneration grade of the proximal adjacent intervertebral disc
evaluated using MRI before and after surgery by the Pfirrmann score. In eight cases, no
Bioengineering 2023, 10, 872 7 of 12

Table 3. Survey about hardware’s perception: “When do you feel the presence of the implants in
your spine?”.

Bioengineering
Bioengineering2023,
2023,10,
10,872
872
Answer Number of Patients 7(%)7 12
of of 12

1. Never 20

change was was observed

observedin inthethePfirrmann
Pfirrmanngrade,grade,whereas
whereasinintwo two cases,
cases, thethe Pfirrmann
Pfirrmann grade
grade
2. Only during weather/temperature change 6
increased.
Finally,
Finally, wewe asked
asked patients
patientstotoreport
reportabout
abouttheirtheirperception
perception ofofthe presence
the presence of of
spinal
spinal
instrumentation,
Occasionallyparticularly
instrumentation,
3. particularlyin incorrelation
correlationwithwiththe theweather
weather andandchanges
changes 1 in
in temperature.
temperature.
The results of of the
the survery
surveryare arereported
reportedininTable
Table3.3.AAtotaltotalofof71%
71% ofofpatients
patients never
neverfeltfelt
thethe
presence
4.
of spinal instrumentation and 21% of patients only
of spinal instrumentation and 21% of patients only felt discomfort
Always
felt discomfort 0 when there
when there
were changes
changes in in weather
weatherand andtemperature.
temperature.Most Mostpatients
patientswithwith titanium
titanium instrumentation
instrumentation
One patient did
complain of not respond to the survey andits
PROMs.
complain of some
some discomfort
discomfort due
dueto to itspresence,
presence,which whichisisincreased
increased when
when there areare
there cli-cli-
matic changes.
matic changes.
In
In Figures
Figures444and
In Figures and
and5,5,5,we
we reported
wereported
reported radiographic
radiographic
radiographic imaging
imaging
imaging concerning
concerning
concerning two
two two cases
cases ofpatients
of
cases pa-pa-
of
tients
affected affected
by DD by
tients affected by DD
thatDD that
were were
thattreated treated with
with CRF-PEEK
were treated CRF-PEEK
with CRF-PEEK posterior
posterior instrumentation
instrumentation
posterior instrumentation and
and TLIF. andIn
TLIF.
the
TLIF. In
first the
the first
Incase, thecase,
first case, the
levelsthe levels
levelstreated
treated were were
wereL4–S1,
L4–S1,
treated and
L4–S1,inandandininsecond
second case,
case, they
second they
were
case, they were
L5–S1.
wereL5–S1.
In both
L5–S1.
In both
In both
cases, wecases, we
we can
can observe
cases, canobserve
the presence
observe the
thepresence ofofa arelevant
of a relevant
presence posterior
relevant posterior
fusion fusion
posterior (Figures
fusion (Figures
4 and 5,
(Figures 4 and
panels
4 and 5, 5,D)
panels
and D) and
interbody interbody
fusion fusion
(Figures 4(Figures
and 5, 4 and
panels 5,
E)panels
at 12 E) at
months
panels D) and interbody fusion (Figures 4 and 5, panels E) at 12 months follow-up. 12 months
follow-up. follow-up.

Figure 4.
Figure 4. Case
Case 1.
1. Female,
Female,4040yo,
yo,DD
DDL4–S1, chronic
L4–S1, low
chronic back
low pain
back andand
pain leg leg
pain, TLIF
pain, and and
TLIF arthrodesis
arthrodesis
Figure 4. Caselumbar
L4–S1. Pre-op 1. Female, 40 MRI
spine yo, DD
(A);L4–S1, chronic
post-op low back
CT sagittal viewpain and CT
(B) and leg at
pain, TLIF and
12 months FUarthrodesis
sagittal
L4–S1. Pre-op lumbar spine MRI (A); post-op CT sagittal view (B) and CT at 12 months FU sagittal
L4–S1. Pre-op
view (C); lumbar
post-op spine MRI
CT sagittal view(A); post-op
(D) and CT
CT at 12sagittal
monthsview (B) andview
FU sagittal CT at(E).12Brantigan
months FU sagittal
score at
view
view (C);
(C); post-op
post-op
12 months FU.
CT
CT sagittal
sagittal view
view (D)
(D) and
and CT
CT at
at 12
12 months
months FU
FU sagittal
sagittal view
view (E).
(E). Brantigan
Brantigan scoreatat
score
12
12months
months FU.
FU.

Figure 5. Case 2. Female, 42 yo, DD L5–S1, chronic low back pain, TLIF and arthrodesis L5–S1. Pre-
op lumbar
Figure spine MRI (A);42
5. Case post-op
DDCT sagittal view (B)
lowand
backCT at 12TLIF
months
and FU sagittal view (C);
Figure 5. Case2.2.Female,
Female, 42 yo,yo, L5–S1,
DD chronic
L5–S1, chronic low pain,
back pain, TLIF arthrodesis L5–S1.
and arthrodesis
post-op CT coronal view (D) and CT at 12 months FU coronal view (E). Brantigan score at 12 months
Pre-
L5–S1.
op lumbar
Pre-op spine MRI (A); post-op CT sagittal view (B) and CT at 12 months FU sagittal view (C);
FU. lumbar spine MRI (A); post-op CT sagittal view (B) and CT at 12 months FU sagittal view (C);
post-op CT coronal view (D) and CT at 12 months FU coronal view (E). Brantigan score at 12 months
post-op CT coronal view (D) and CT at 12 months FU coronal view (E). Brantigan score at 12 months FU.
FU.
Table 3. Survey about hardware s perception: “When do you feel the presence of the implants in
4.your
Discussion
spine?”.
Table 3. Survey about hardware s perception: “When do you feel the presence of the implants in
CFR-PEEK
your spine?”. is an innovative composite material combining the deformability of PEEK
Answer Number of Patients (%)
with the strength of carbon fibers, and it offers several advantages compared with the
1. Never Answer 20 Patients (%)
standard materials (i.e., Ti6Al4V alloys) used in the spineNumber
field. Itsof
mechanical properties
2. Only during weather/temperature change 6
1. Never 20
3. Occasionally 1
2. Only during weather/temperature change 6
4. Always 0
3. Occasionally 1
One patient did not respond to the survey and PROMs.
4. Always 0
Bioengineering 2023, 10, 872 8 of 12

depend on the carbon fibers’ amount, alignment, and length, and they are typically tuned
to match the properties of human bone [6]. The bending and compressive moduli and
the strength are comparable or even superior to that of cortical bone [14], but the bending
stiffness, yield and ultimate loads, and fatigue strength were found to be comparable
with or higher than traditional titanium alloys [15], with the torsional stiffness and yield
torque being suitable to withstand the physiological loads. The additional advantages for
using CFR-PEEK in the spine field relies on good biocompatibility, an enhanced osteogenic
property, and bioactivity [19,20], while radiolucency and CT/MRI artifact-free features may
offer additional advantages over traditional metallic systems, both for routine imaging and
radiotherapy treatments. From an imaging perspective, CRF-PEEK instrumentation allows
for an improved evaluation of adjacent anatomic structures during radiography, CT, and
MRI scans. This results in improved post-operative surveillance imaging as well as an easier
visualization of the anatomy for image-guided percutaneous interventions. In radiation
oncology treatment, CRF-PEEK devices are also advantageous due to their decreased
imaging artifact during planning and decreased dose perturbation during RT delivery. For
these reasons, the manufacturing processes for CRF-PEEK materials continue to evolve and
improve, and orthopedic applications for them in the spine and the appendicular skeleton
are increasing [8,9].
Previous biomechanical preclinical studies have confirmed the effectiveness and ef-
ficacy of CFR-PEEK material for use in interbody fusion and vertebral reconstruction in
oncologic patients. Brantigan et al. pioneered the usage of CFR-PEEK PLIF cages and
provided comparable compressive stiffness as the intact spine, but higher strength and
superior pull-out resistance compared with bone allografts [27]. Disch et al. [28,29] re-
ported that CFR-PEEK vertebral body replacements (VBRs) could provide effective primary
stability with long posterior fixation following en bloc spondylectomy, and it had a similar
performance to expandable titanium devices [28,29]. The first case series of bone tumors of
the spine surgically reconstructed with a new, custom, fully radiolucent, polyetherether-
ketone/carbon fiber (PEEK/CF) vertebral body replacement (VBR) integrated system has
been recently reported [30]. More recently, rods and pedicle screws for spinal stabiliza-
tion have also been realized using CRF-PEEK material [15]. Previous findings support
the osteoconductive properties of CFR-PEEK, which has mechanical properties that are
comparable with the surrounding bone, thus ensuring more homogeneous stress and strain
distributions at the bone–screw interface, minimizing micromotions, and promoting an
enhanced load-sharing on the anterior column. This biomechanical rationale also explains
the results of recent clinical studies that support reduced cage subsidence and enhanced
osteointegration and fusion.
Boriani et al. [10] studied the safety and efficacy of a CFR-PEEK composite rod and
screw fixation system compared with titanium implants. Thirty-four patients who under-
went thoracic and lumbar spinal fixation for spinal tumors using CFR-PEEK composite
implants were followed for a mean of 13 months. Early follow-up findings revealed neuro-
logical improvement and improved pain control. Only one intraoperative screw breakage
occurred out of 232 implanted screws, and the loosening of 2 sacral screws was detected
at 12 months. The authors reported that six local recurrences were detected early thanks
to the implant radiolucency. Additionally, they described a case series of six patients who
underwent poster fixation of the cervical spine using a hybrid system containing CFR-PEEK
screws and rods with polyester bands and titanium clamps. In this report, no intraoper-
ative complications occurred in any of the patients [12]. Tedesco et al. [11] presented a
study on 22 patients who underwent spinal stabilization using a CFR-PEEK system with
a median follow-up of 10 months. The authors reported only one intraoperative screw
breakage, which occurred in the absence of rod breakage, during the follow-up period.
This was supported by Laux et al. [31] who demonstrated that CFR-PEEK implants have no
increased risk of perioperative instrumentation complications. Pipola et al. [32] presented
a case of a patient who underwent an en bloc resection with an anterior and posterior
approach for the treatment of sclerosing epithelioid fibrosarcoma and spinal fixation using
Bioengineering 2023, 10, 872 9 of 12

composite PEEK-CF rods, and a 2-year follow-up proved the implant’s stability with no
local recurrences found. Based on these results, CFR-PEEK possesses a similar efficacy
profile to that of the standard titanium instrumentation but has an increased safety profile
with respect to the early detection of tumor recurrency.
In addition to evaluating the dosimetric impact caused by CFR-PEEK,
Mastella et al. [33] analyzed the CT phantoms of the two screws that were acquired to
evaluate image quality. CFR-PEEK screws did not create appreciable artifacts on the CT
scans compared with titanium implants, thus improving dose accuracy and image quality.
Ringel et al. [13] reported a reduction in screw artifacts in MRI and CT scans for CFR-
PEEK implants compared with titanium implants. All of these papers report about the
clinical applications of CRF-PEEK systems for the treatment of spinal tumors, and the
advantages of radiolucency and artifact-free imaging are very attractive for radiotherapy
and treatment monitoring.
Fleege et al. [22] recently compared two groups of patients that were treated for
degenerative spinal disorders of the lumbar spine using titanium pedicle screws or CF-
PEEK pedicle screws. All patients underwent an MRI assessment within the first four
postoperative weeks. CF-PEEK pedicle screws exhibited smaller artifact areas on the
vertebral body surfaces and their surrounding tissues due to them having a lower density
than titanium (similar to bone), which significantly improved the radiographic assessability.
The osteoconductive properties of CFR-PEEK are considered to also be optimal for
pedicle screw anchorage because stress and strain gradients may be minimized at the
screw–bone interface, thus improving short-term primary stability and enhancing long-
term secondary stability throughout osteointegration. Several preclinical in vitro studies
have confirmed this idea; they have reported higher axial pullout strength for CFR-PEEK
poly-axial pedicle screws compared with titanium screws [15] and reduced screw loosening
when used for the semi-rigid stabilization of osteoporotic spines [18]. Based on these
advantageous characteristics, we proposed conducting a pilot study on degenerative
lumbar patients that were entirely treated using CFR-PEEK instrumentation.
We analyzed a case series of 28 patients and observed a high rate of spinal fusion
(89% of cases), which is comparable with the results reported in the literature for titanium
implants [34]. Moreover, no mechanical complications such as screw mobilization, rod
breakage, or cage subsidence were recorded during the follow-up period. These encour-
aging radiographic outcomes were associated with a significant improvement of clinical
outcomes, as measured by PROs, including pain reduction and the improvement of the
health-related quality of life.
A few biomechanical, comparative, in silico studies [23,24] have studied the usage
of CFR-PEEK for semirigid posterior stabilization, and they can be used to interpret the
results of the clinical study collected here. The osteoconductive properties of CFR-PEEK
promote a better load-sharing on the anterior column and an improved osteointegration
compared with more rigid posterior instrumentations.
Comparative biomechanical studies also demonstrate that semi-rigid posterior stabi-
lization using CFR-PEEK could reduce the loads (specifically the intradiscal pressure, facet
joint force, and interspinous and supraspinous ligaments elongation) on the adjacent proxi-
mal disc compared with stiffer materials, such as titanium alloys and stainless steel [23,24].
According to a meta-analysis, the pooled incidence of ASD after lumbar fusion surgery
was 26.6% [35]. In our study, only nine patients had pre-operative and post-operative MR
imaging, which allowed for a comparison of the adjacent proximal disc degeneration before
and after surgery. In all cases, a pre-existing adjacent segment degeneration (ASD) was
detected, and we observed only one case of worsening degeneration following surgery.
However, the limited amount of data regarding the characteristics of the adjacent proximal
disc does not allow us to attribute a greater efficacy of the carbon implants to preserve the
adjacent disc from degeneration compared with titanium.
Moreover, the effect of cold weather has been investigated in patients with orthopedic
implants, but this was not related to any specific implant type, material, or site [36]. The
Bioengineering 2023, 10, 872 10 of 12

results of the survey that we conducted indicates that patients’ sensitivity to the presence of
instrumentation during weather changes (i.e., temperature and humidity) is low, which may
depend on the intrinsic thermal properties of CFR-PEEK, such as the coefficients of thermal
expansion and thermal conductivity, which are in the same range as the parameters reported
for human cortical and highly mineralized trabecular bone (Table 4). Although a direct
comparison with patients treated with traditional titanium implants is not available, this
aspect may require further investigation to establish the specific factors that are involved in
patients’ sensitivity to implant material.

Table 4. Thermal properties of CFR-PEEK and bone.

Trabecular
CFR-PEEK Cortical Bone
Bone
4÷6
Coefficients of thermal expansion [37] 2.8 ± 0.4
n.a.
(×10−5 mm/K) 5.4 ÷ 39 [39]
[38]
0.66 0.39 ± 0.06
[37] 0.68 ± 0.01 [41]
Thermal conductivity (W/m·K)
0.95 [40] 0.26 ÷ 0.33
[38] [42]

5. Conclusions
Despite some relevant limitations, due to the small cohort of patients analyzed and
the lack of a control group treated using traditional titanium implants, this is the first
clinical study supporting the safety and efficacy of implants that are entirely constructed
out of CRF-PEEK for spinal stabilization in patients affected by degenerative diseases. Our
study demonstrates that the use of CRF-PEEK implants is associated with good clinical and
radiographic outcomes, a high fusion rate, the reduction of pain, and the improvement of
quality of life. The preliminary data also suggest a preservation of the adjacent proximal
disc degeneration and a good tolerability of the instrumentation for the patients. These
advantageous characteristics, which are associated with the reduction of imaging artifacts
in CT and MRI procedures, support the use of CRF-PEEK implants as a valid alternative to
conventional titanium devices for spinal stabilization in degenerative patients.
Further investigations can be performed to evaluate the effect of CRF-PEEK instrumen-
tation on adjacent segments compared with titanium devices and to analyze the tolerability
of the material; these aims are important in order to identify possible selection factors
for patients who may benefit more from the use of CFR-PEEK implants compared with
titanium ones.

Author Contributions: Conceptualization, R.G. and M.G.; methodology, G.T. (Giovanni Tosini)
and R.G.; validation, V.P., G.B.B. and S.B.; formal analysis, A.M. and L.E.N.; investigation, R.G.,
C.G. and L.L.B.; data curation, A.L.; writing—original draft preparation, G.T. (Giovanni Tosini),
C.G., L.L.B. and A.L.; writing—review and editing, S.T., G.T. (Giuseppe Tedesco), G.E. and L.F.;
supervision, A.G.; funding acquisition, A.G. All authors have read and agreed to the published
version of the manuscript.
Funding: This study was supported by the Italian Ministry of Health grant 5x1000- year 2020.
Institutional Review Board Statement: The study was conducted in accordance with the Declaration
of Helsinki and was approved by the local ethics committee (Comitato Etico di Area Vasta Emilia
Centro) on October 2014 (protocol number 0033475) and on July 2018 (protocol number CE-AVEC:
208/2018/Disp/IOR).
Data Availability Statement: Data supporting the reported results can be retrieved by asking to the
corresponding authors.
Bioengineering 2023, 10, 872 11 of 12

Acknowledgments: The authors thank Carlo Piovani for his helpful collaboration in image archiving
and editing.
Conflicts of Interest: The authors declare no conflict of interest.

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