Keywords
3D bioprinting - SCI surgery - bioengineering - cost-efficiency - neuroregeneration
Introduction
Spinal cord injury (SCI) is considered to be one of the most challenging central nervous
system injuries. The serious complications and high rates of paraplegia caused by
SCIs have brought a great burden to individuals, families, and society.[1] As nerve cells become damaged or degenerate, they cannot be repaired on their own
the way other cells do, and this can lead to lifelong loss of function. From a pathological
perspective, there are two main causes of SCI: primary injury and secondary injury.
The primary injury occurs primarily as acute injuries caused by mechanical forces
such as extrusion and dislocation, which cause damage to neurons or glial cells in
corresponding sections that result in hemorrhage.[2] Secondary injury can be relatively complicated and have multiple potential mechanisms,
including local edema, ischemia, free radical excess, and intense inflammatory responses.[3] Furthermore, differentiation of neurons is influenced by both primary and secondary
injury. These changes can lead to cystic lesions, while astrocyte proliferation leads
to the formation of scar tissue.[4] The formation of dermal scar tissue also prevents the regeneration of neurons, leading
to the loss of natural sensation and volitional action.[4]
At present, the clinical treatment of SCI is mainly divided into nonsurgical treatment
and surgical treatment. One of the nonsurgical treatments for SCIs is postinjury shock
therapy with excessive doses of methylprednisolone (MP).[5] MP is a corticosteroid that inhibits the peroxidation of lipids. It also reduces
the inflammatory response, protects the blood–brain barrier of the spinal cord, and
increases the vascular flow to the injured spine when employed as a scavenging agent
for free radicals. However, some adverse effects limit the use of this medicine, as
its therapeutic benefits are also controversial, including an increased risk of urinary
tract, respiratory, and wound infections.[6] Decompression and fixation have always been the most important techniques for the
surgical treatment of SCIs. Eliminating compression factors and restoring spinal structure
to the most stable state is a key aim of SCI therapy.[7] Some progress has been made in repairing SCIs with these methods; however, at the
present time, all clinical treatment techniques can only address injury factors to
a limited extent and are not yet capable of creating functionally functional nerve
regeneration. It is therefore concluded that the injury has not been repaired to its
full extent.[8]
The three-dimensional printing (3DP) approach to health care and surgery has come
a long way since its introduction, with an apparent increase in interest only over
the last several years. It is currently regarded as one of the most recent and sophisticated
tools in orthopaedic surgery. To improve the precision and reproducibility of surgical
techniques, 3DP is widely promoted and applied in a wide range of orthopaedic subdisciplines.
This has been possible due to parallel advances made both in medical imaging and bioengineering
([Fig. 1]). The demand for the technology is only going to increase with more and more emerging
technologies that are becoming available on a day-to-day basis.[9] It is most frequently used for complicated regions, such as spine or pelvic surgery,
which can be seen with the increasing number of articles available in recent years.[10] The literature relating to 3DP in spine care is largely based on case reports and
series of cases, although there has been some progress over the last decade. However,
the technology of 3DP is expensive, time-consuming, and requires specialized personnel
and equipment. In addition, its use has been restricted to specialist centers of care
due to strict regulations in place.[11]
Fig. 1 This figure depicts the development of a three-dimensional (3D) ex vivo fiber testing
model that replicates a peripheral nerve injury. This model can be used to test new
materials for peripheral nerve repair. Nerve guide conduits (NGCs) are 3D printed
and fibers manufactured by electrospinning are threaded into NGCs. Dorsal root ganglia
are dissected and explanted on top of the NGC. The NGCs and dorsal root ganglia (DRGs)
are incubated in cell culture medium for 21 days. Fibers can then be removed, immunolabeled
with specific cell antigens and imaged with confocal microscopy for analysis.
This review aims to provide a brief introduction to this technology and draw attention
to the existing evidence that underpins various spine care applications. Additionally,
it includes discussions on the limitations of 3DP technology and the challenges it
faces for further expansion.
Materials and Methods
PICOT
-
- Population (P): This systematic review focuses on adults aged 18 years and above
with degenerative spinal cord conditions or SCI.
-
- Intervention (I): The intervention of interest is the use of 3DP technology for
creating spinal implants, surgical tools, or simulating preoperative procedures.
-
- Comparison (C): Studies comparing 3DP technology with conventional surgical methods
or non-3D-printed spinal interventions are included, as well as studies focusing on
3DP interventions.
-
- Outcome (O): The primary outcomes of interest include the assessment of the effectiveness,
safety, and long-term outcomes of 3DP technology in treating degenerative spinal conditions.
This encompasses factors such as patient recovery, postoperative complications, pain
management, and the necessity for reoperation.
-
- Timeframe (T): The systematic review includes studies published between 2019 and
2023.
To be eligible for inclusion in this systematic review, studies were required to meet
the following criteria: a population of adults aged 18 years and above who have experienced
a spinal cord degenerative condition or SCI; provide data that enables the evaluation
of the efficacy, safety, and enduring consequences of 3DP technology in the treatment
of degenerative spinal conditions, including aspects such as patient recovery, postoperative
complications, pain control, and the necessity for subsequent surgical intervention;
and be published in the English language between 2019 and 2023. Study designs eligible
for inclusion are randomized controlled trials (RCTs), cohort studies, longitudinal
studies, and case reports.
Studies meeting any of the following criteria were excluded from the systematic review:
a population of pediatric patients (age < 18 years); involving patients with diagnoses
other than spinal cord conditions; do not provide data on the aforementioned outcomes;
and languages other than English or published before 2019. Review articles, letters
to the editor, and gray literature were excluded. Studies for which the complete text
was not accessible were also excluded.
Study Screening and Selection
Study screening and selection were conducted using the Rayyan software. Two independent
reviewers assessed titles and abstracts for eligibility based on the inclusion and
exclusion criteria outlined above. Any disagreements between reviewers were resolved
through discussion or by involving a third reviewer if necessary.
Assessment of Methodological Quality and Risk of Bias
The methodological quality and risk of bias of the included studies were assessed
using the Cochrane Risk of Bias 2 (RoB-2) tool and Newcastle-Ottawa Scale.
Literature Search
A comprehensive literature search was conducted in PubMed. The search strategy combined
relevant keywords and Medical Subject Headings (MeSH) where applicable.
The search terms used were ((“Printing, Three-Dimensional”[MeSH]) OR (3D Printing)
OR (3D bio printing)) AND ((Spinal Degenerative Disease) OR (Spinal cord injury)).
Data Extraction
A standardized data extraction form was developed and used to extract relevant information
from the included studies. Data extraction covered study characteristics, participant
details, intervention descriptions, outcome measures, results, and adverse events
related to 3DP.
Results
Initially, a search of the PubMed database yielded a total of 89 articles. After meticulous
screening based on title, abstract, and full text, 11 studies met the inclusion criteria.
The present study involved the analysis of patient-level data from various study designs,
encompassing a cohort of 237 individuals with spinal cord conditions.
The average age of the patients was 51 years, with 108 individuals identified as male,
accounting for 45.57% of the total sample. Only one study did not mention the male-to-female
ratio. [Table 1] provides an overview of patient characteristics, including their initial symptoms
and the duration of these symptoms. [Table 2] presents a comprehensive overview of the role of 3DP in managing the patients' conditions.
[Table 3] offers a detailed overview of perioperative conditions, along with patient details
regarding the duration of follow-up and prognosis.
Table 1
Clinical characteristics and outcomes of 237 patients across multiple studies, detailing
spinal degenerative conditions, patient demographics, fusion rates, and presenting
symptoms
Study ID
|
No. of patients
|
Gender
(M:F)
|
Mean age
|
Spinal degenerative condition
|
Fusion rate
|
Patient presentation
|
Yoo 2019[13]
|
10
|
9:1
|
50.1
|
Spinal cord injury
|
−
|
Impaired hand function
|
Sun 2023[14]
|
26
|
14:12
|
56.5
|
Metastatic epidural spinal cord compression
|
21.50%
|
Low back pain
|
Kapadia 2021[20]
|
8
|
5:3
|
46.7
|
Spinal cord injure
|
−
|
Impaired hand function
|
Yeh 2023[12]
|
8
|
6:2
|
34.5
|
Spinal cord injure
|
−
|
Impaired hand function
|
Shin 2021[18]
|
4
|
4:0
|
59.7
|
Severe quadriplegia
|
−
|
Quadriplegia
|
Jin 2021[19]
|
30
|
18:12
|
60.2
|
Cervical degeneration
|
100%
|
Cervical pain and arms
|
Mokawem 2019[21]
|
93
|
43:50
|
61.0
|
Lumber degeneration
|
98.8%
|
Low back pain and lower extremities
|
Petrone 2020[16]
|
37
|
−
|
57.9
|
Lumber degeneration
|
92.4%
|
Low back pain and lower extremities
|
Cao 2023[17]
|
10
|
5:5
|
55.4
|
Thoracolumbar metastasis
|
−
|
Low back pain and lower extremities
|
Segi 2023[15]
|
11
|
6:5
|
74.7
|
Lumber degeneration
|
−
|
Low back pain and lower extremities
|
Abbreviations: F, female; M, male.
Table 2
Overview of perioperative 3D printing interventions, including the types of 3D printing
participation, materials used, associated costs, and the software employed in the
management of various spinal conditions
Type of 3D printing participation
|
Material used for 3D printing
|
Cost for 3D printing
|
Software used
|
3D-printed hand orthosis
|
Nylon
|
250$ US
|
SolidWorks, Dassault Systèmes, and France software
|
Preoperative 3D simulation/printing
|
−
|
5,000$ US
|
Reconstruction software (Mimics Innovation Suite 21.0)
|
Rehabilitation hand function
|
–
|
2,500$ US
|
GRASSP
|
3D-printed hand orthosis
|
–
|
65$ US
|
Design Simulation Technologies
|
Power wheelchair joysticks
|
|
−
|
Mimics Innovation Suite 14.0 software
|
3D-printed interbody fusion cages
|
Titanium
|
−
|
–
|
3D-printed lamellar titanium cages
|
Silicate substituted calcium phosphate bone graft
|
−
|
Surgimap Spine software
|
Preoperative surgical simulation
|
–
|
–
|
Mimics Innovation Suite software
|
3D-printed autostable artificial vertebral body
|
Polylactic acid
|
–
|
Mimics Innovation Suite 17.0 software
|
3D-printed porous titanium cage
|
Titanium
|
–
|
–
|
Abbreviation: 3D, three-dimensional.
Table 3
Outcomes and follow-up of patients undergoing 3D printing-assisted spinal interventions,
including complication rates, hospital stay durations, and intraoperative metrics.
Among the sample, 26 patients had dural damage, with 82.28% achieving favorable outcomes
during follow-ups ranging from 2 weeks to 2 years
Primary outcome measure
|
Incidence of reoperation
|
Intraop duration
|
Intraop blood loss
|
Hospital stay duration
|
Complications
|
Outcome
|
Prognosis
|
Follow-up
|
The Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) and functional independence
in daily living
|
–
|
–
|
–
|
–
|
−
|
Patients were satisfied with the effectiveness of orthosis
|
Good
|
−
|
The Toronto Rehabilitation Institute Hand Function Test (TRI-HFT)
|
–
|
2.15 ± 0.25 h
|
478.85 ± 125.83 mL
|
–
|
Dural damage in 11 cases
|
6 improvements, 18 small improvements, 2 no improvement
|
–
|
2 y
|
The Toronto Rehabilitation Institute Hand Function Test (TRI-HFT)
|
–
|
–
|
–
|
–
|
−
|
–
|
–
|
6 mo
|
Box and block test, Spinal Cord Independence Measures III questionnaire
|
–
|
–
|
–
|
–
|
−
|
Help in the early stage of C-SCI to learn and use tendinosis easily
|
–
|
2 wk
|
PIDA assessment, NASA-TLX index, PIADS index
|
–
|
–
|
–
|
–
|
−
|
Improvement of driving abilities and more psychological satisfaction
|
Good
|
2 wk
|
JOA score
|
0%
|
–
|
–
|
–
|
No
|
Restore curvature of the cervical spine
|
Good
|
65.23 ± 3.54 mo
|
CT and Oswestry Disability Index
|
2.2%
|
–
|
–
|
4–6 d
|
Intraoperative endplate damage, fracture, segmental bleeding, new pain, chest infection,
thrombosis
|
Excellent fusion rate and ODI = 21–43
|
Good
|
12 mo
|
VAS score
|
0%
|
124 min
|
–
|
2.2 d
|
No
|
Excellent fusion rate
|
Good
|
32.2 mo
|
VAS score and Frankel grading
|
–
|
8.1 ± 2.3 h
|
1614.3 ± 1052.6 mL
|
–
|
Hypoesthesia, leakage of CSF
|
Shorter operation time, less bleeding, and faster recovery
|
Good
|
21.8 mo
|
Marchi classification
|
–
|
–
|
–
|
–
|
Thigh pain
|
Lower cage subsidence successfully
|
Good
|
12 mo
|
Abbreviations: C-SCI, cervical spinal cord injury; CSF, cerebrospinal fluid; CT, computed
tomography; JOA, Japanese Orthopaedic Association; ODI, Oswestry Disability Index;
NASA-TLX, National Aeronautics and Space Administration-Task Load Index; PIADS, Psychosocial
Impact of Assistive Devices Scale; PIDA, Power-Mobility Indoor Driving Assessment;
VAS, Visual Analog Scale.
Data provided in [Table 1] reveals that out of the total sample of 237 patients, 9.28% reported impaired hand
function as a result of SCI.[3]
[12]
[13] Additionally, 237 patients, making up 10.97% of the sample, cited low back pain
as their presenting complaint, primarily due to metastatic epidural spinal cord compression.[14] A significant portion, comprising 36.71% of the patients, presented with both low
back pain and lower extremity deficits.[15] Among these, 130 patients suffered from lumbar degeneration,[16] 10 patients had en bloc resection of thoracolumbar metastasis,[17] and 11 patients suffered from lumbar degenerative disease or adult spinal deformity.
A smaller percentage, 1.69%, presented with quadriplegia,[18] and only 12.66% reported cervical and arm pain due to cervical degeneration.[19]
Based on the data provided in [Table 2], it is evident that perioperative 3DP was employed for all patients. Among them,
9.28% of patients were managed with 3D-printed hand orthosis, utilizing SolidWorks,
Dassault Systèmes, and France software.[13] Preoperatively, 10.97% of patients underwent 3D simulation/3DP using reconstruction
software (Mimics Innovation Suite 21.0).[14] Notably, 36.71% of the patients were managed with various 3D-printed interventions,
including lamellar titanium cages, preoperative surgical planning through 3D and multiplanar
reconstruction, autostable artificial vertebral bodies, and porous titanium cages.
These were executed using Surgimap Spine software, Mimics (Materialise, Leuven, Belgium),
and Mimics 17.0 software, respectively.[16]
[17]
[21] A smaller proportion, 1.69% of patients, were managed with power wheelchair joysticks,
employing Mimics Innovation Suite 3-matic ver. 14 (Materialise) software.[16] Lastly, 12.66% of the patients received treatment involving 3D-printed interbody
fusion cages.[19]
The data presented in [Table 3] illustrates the outcomes and follow-up of patients. Among the sample, 26 patients
had dural damage, with 11 of them experiencing complications.[14] Additionally, 93 patients faced complications such as intraoperative endplate damage,
fracture, segmental bleeding, new pain, chest infection, and thrombosis. Only 10 patients
experienced hypesthesia and cerebrospinal leakage, showing a lower incidence compared
to patients who did not benefit from 3DP techniques.[17] Furthermore, 11 patients had thigh symptoms,[15] while 97 patients did not encounter any complications.[16]
Follow-up duration ranged from 2 weeks to 2 years. Note that 82.28% of the total sample
had a favorable outcome.
Discussion
A 3D-printed hand orthosis was developed to improve hand function and functional independence
for patients with cervical SCIs (C-SCIs).[13] The orthosis proved effective in enhancing hand function, as indicated by significant
improvements in the Toronto Rehabilitation Institute Hand Function Test (TRI-HFT)
and functional independence in daily living, particularly in tasks like eating. Notably,
the orthosis demonstrated cost-effectiveness, customizability, and lightweight attributes
compared with alternative assistive devices, making it a promising solution for individuals
with C-SCIs. A 3D-printed orthosis with a triple four-bar linkage was designed to
enhance hand function and functional independence for patients with chronic C-SCIs.[12] The results revealed that the orthosis significantly improved pinch force and hand
dexterity, although it did not demonstrate substantial improvements in self-care abilities.
This suggests that orthosis may be especially beneficial for individuals in the early
stages of chronic C-SCIs, offering them an easier means of utilizing the tenodesis
grip.
The potential of 3DP in the treatment of symptomatic metastatic epidural spinal cord
compression are as follows: Patients who received preoperative 3D simulation/3DP-assisted
surgery exhibited favorable outcomes, including reduced operation time, lower blood
loss, and decreased complications when compared with the nonsimulated group.[10] While there were no significant differences in pain relief and postoperative neurological
function improvement, the study highlighted that 3DP technologies can practically
enhance surgical procedures for this condition.
Researchers assessed the applicability of the 3D TRI-HFT in evaluating unilateral
hand gross motor function for individuals with SCIs.[20] The results indicated high reliability of the 3D TRI-HFT for both subacute and chronic
SCI cases, with strong correlations observed between the assessment and functional
independence measures. This finding supports the utility of the 3D TRI-HFT as a reliable
and valid tool for evaluating hand gross motor function, thereby facilitating more
comprehensive care for individuals with SCI.
Power wheelchair driving for patients with quadriplegia by creating customized joysticks
using 3DP technology has been developed.[18] The results were highly encouraging as all patients showed improvements in their
power wheelchair driving abilities, reporting greater satisfaction with the customized
joysticks. These customized joysticks not only reduced workload and improved performance
but also enhanced self-efficacy and reduced negative emotional reactions associated
with disability. The study effectively demonstrated the potential of 3DP to create
tailored aids, enhancing the convenience and quality of life for patients with severe
disabilities.
Patients with cervical spondylotic myelopathy were investigated using 3D-printed interbody
fusion cages in anterior cervical discectomy and fusion (ACDF).[20] The results, derived from a long-term follow-up, revealed several benefits. Patients
who received 3D-printed cages experienced significant improvements in their symptoms,
quality of life, neurological function, cervical curvature, intervertebral height,
and fusion rate. Importantly, the study noted the safety and stability of 3D-printed
cages in ACDF and their advantages over traditional cages, as no severe complications
or cage subsidence were observed.
A retrospective review of prospectively collected data explored the use of silicate-substituted
calcium phosphate (SiCaP)-packed 3D-printed lamellar titanium cages in lumbar surgery
for degenerative diseases and deformities.[21] The findings demonstrated that these cages achieved a high fusion rate with excellent
integration and improvements in patient-reported outcomes. Minor complications, unrelated
to the cages, were recorded, affirming their safety and effectiveness in lumbar surgery.
The study involved patients undergoing lumbar fusion with cortical bone trajectory
(CBT) screws and interbody fusion. Patients were categorized into three groups based
on the surgical technique.[2] The research emphasized that CBT techniques were safe and reliable, especially with
precise preoperative computed tomography (CT) scan-based planning. The use of 3D template
patient-matched guides yielded superior results, enhancing accuracy, reducing operative
time, and lowering complication rates. The clinical outcomes were satisfactory, featuring
significant improvements in pain and disability scores. A high fusion rate was observed
in patients with longer follow-up periods.
Patients with thoracolumbar metastases who underwent en bloc resection and reconstruction
using either 3D-printed autostable artificial vertebrae or titanium cages were examined.[17] The results indicated that the 3D-printed artificial vertebrae led to numerous advantages,
including reduced operation time, decreased blood loss, fewer complications, and faster
fusion. Patients in the observation group experienced lower rates of nerve-related
issues, such as paralysis, weakness, hypoesthesia, and infection, without any significant
difference in survival, pain levels, or spinal function recovery.
Promising results are evident with 3D-printed vertebrae printed using both bioinks
and biomaterial inks ([Fig. 2]).
Fig. 2 This figure shows how both bioinks and biomaterial inks can be used as an alternative
to synthetic inks in three-dimensional (3D) printing.
A retrospective analysis compared the use of two types of cages—3DTi and sPEEK—in
anterior and posterior combined surgery with extreme lateral interbody fusion for
lumbar degenerative disease or adult spinal deformity.[15] The findings showed that the 3DTi cage demonstrated significantly less vertebral
endplate concavity (VEC) and cage subsidence when compared with the sPEEK cage, both
immediately and 3 months postsurgery. Moreover, the 3DTi cage exhibited superior correction
and maintenance of the local lordotic angle. The study concluded that the 3DTi cage
reduced endplate injuries during cage insertion, suggesting its effectiveness in enhancing
spinal deformity corrections.
Effectiveness of 3D Printing
Effectiveness of 3D Printing
The effectiveness of 3DP is providing valuable preoperative information to surgeons,
aiding in enhanced surgical planning, and simplifying procedures.[14] The simulated group, which underwent 3D digital simulation before surgery, demonstrated
better clinical outcomes compared with the nonsimulated group, with improvements in
operation time, blood loss, screw adjustments, fluoroscopy use, and a lower incidence
of dural injury or cerebrospinal fluid leakage. Although there was no significant
difference in terms of pain relief, neurological function improvement, and tumor recurrence,
the study emphasizes the benefits of 3DP in surgical planning.
The effectiveness, improvement, and safety of a 3D-printed hand orthosis for patients
with C-SCI is remarkable.[12] The results indicate a remarkable 558% increase in pinch force after wearing the
assistive device, with further improvements during the 2-week follow-up period. Additionally,
there was a 37% enhancement in hand dexterity postassistive device use. These findings
emphasize the substantial improvement provided by the 3D-printed hand orthosis in
terms of hand function, highlighting its effectiveness and safety.
3DP technology was employed to create customized power wheelchair joysticks for patients
with severe quadriplegia.[18] The study reveals that all patients experienced improvements in their power wheelchair
driving abilities and expressed greater satisfaction with the customized joysticks.
The joysticks were noted for their lightweight design, simplicity, and ease of use.
These findings underscore the safety and effectiveness of 3DP technology in customizing
aids to enhance the mobility and satisfaction of patients with severe disabilities.
The effectiveness of 3D-printed lamellar titanium cages and SiCaP bone grafts in achieving
spinal fusion is exceptional.[21] The 98.9% fusion rate observed at 12 months postsurgery, with 92 out of 93 patients
achieving solid fusion, emphasizes the reliability and success of using 3D-printed
cages and SiCaP grafts for spinal fusion procedures.
The CBT technique is a dependable alternative to traditional pedicle screws in posterior
lumbar fusion.[16] It indicates that the CBT technique offers multiple advantages, including reduced
muscle damage, decreased blood loss, shorter operation times, perioperative pain,
and hospital stays compared with traditional pedicle screws. This underlines the effectiveness
of the CBT technique in achieving positive clinical and radiological outcomes.
Impact and Improvement after 3D Printing
Impact and Improvement after 3D Printing
3D-printed hand orthosis improved hand function and activity of daily living (ADL)
(related to eating) in clinical tests, such as TRI-HFT, Functional Independence Measure
(FIM), and Spinal Cord Independence Measure (SCIM) III.[13] The myoelectric orthosis, designed to enhance grip through tenodesis, significantly
improved hand function, particularly in grasp, lift, and object manipulation. Statistically
significant improvements were observed in most items of the TRI-HFT, particularly
when dealing with objects of various sizes and shapes. Larger objects, such as a mug,
paper, or a dice, showed significant improvement. However, no significant improvements
were noted when handling smaller or relatively flat objects like a book, credit card,
mobile phone, or pencil. In the second part of the test, which assessed the strength
and stability of grip using wooden blocks, participants were able to handle objects
efficiently, regardless of weight and friction. Most subjects showed statistically
significant improvements in this part. Significant improvements were observed in the
total SCIM III and FIM scores, indicating enhanced independence in daily activities.
Notably, the most affected ADL category, eating, displayed significant improvement
in FIM scores, emphasizing the impact of improved hand function on this task. However,
other ADL tasks, such as grooming, bathing, and dressing, did not show significant
improvements, suggesting that fine motor function and lower extremity abilities were
not significantly affected by the orthosis. Participants provided feedback on the
orthosis' usability and effectiveness. Overall, subjects were satisfied with the orthosis'
effectiveness, giving it high scores. While some mentioned that the orthosis' dimensions
were somewhat bulky due to the linear motor and challenging to adjust, most participants
expressed satisfaction with the developed orthosis.
For 3D simulation/3DP-assisted surgery for symptomatic metastatic epidural spinal
cord compression of posterior column, the Visual Analog Scale (VAS) scores of the
stimulated group improved significantly after the treatment and at the last follow-up
compared with before the treatment.[14] VAS score is a measure of pain intensity. The American Spinal Injury Association
(ASIA) grading of the stimulated group also improved after the treatment. ASIA grading
is a measure of neurological function based on sensory and motor assessments. The
stimulated group showed significant or slight improvement in 20 out of 20 patients,
while the nonstimulated group showed improvement in 24 out of 26 patients. This suggests
that electrotherapy can enhance the recovery of neurological function in fibromyalgia
patients. The simulated group had a shorter operation time (1.94 hours) compared with
the nonsimulated group (2.15 hours). Intraoperative blood loss was lower in the simulated
group (382.50 mL) compared with the nonsimulated group (478.85 mL). The simulated
group had a lower screw adjustment rate (12.33%) compared with the nonsimulated group
(21.50%). The simulated group required fewer intraoperative fluoroscopy times (1.30)
compared with the nonsimulated group (1.73). Fewer patients in the simulated group
experienced dural damage/cerebrospinal fluid leakage (3 patients) compared with the
nonsimulated group (11 patients). Both groups experienced significant relief of low
back pain symptoms after surgery. There was no significant difference in pain scores
before and after surgery between the two groups. Neurological function improved in
both groups, and there was no significant difference in the improvement of neurological
function between the two groups. During the 2-year follow-up period, 25% of patients
in the simulated group and 34.61% in the nonsimulated group experienced a relapse,
but there was no statistical difference between the two groups.
After wearing the 3D-printed hand orthosis device, the pinch force significantly increased
to 1.71 lb, representing a 558% improvement compared with baseline.[12] During the 2-week follow-up assessment, the average pinch force further increased
to 1.86 lb. After wearing the assistive device (posttest), patients took an average
of 17.75 blocks, showing a 37% improvement in hand dexterity compared with baseline.
The improvement in hand dexterity between the posttest and the 2-week follow-up assessment
was statistically significant, indicating that hand dexterity continued to improve
after 2 weeks of using the device. Among the self-care items, grooming showed a slight
improvement after wearing the assistive device, but the difference was not statistically
significant. The average grooming score was 1 point at baseline and 1.25 points in
both posttest and 2-week follow-up assessments.
The study used the Power-Mobility Indoor Driving Assessment (PIDA) to evaluate the
patients' driving abilities with the customized joysticks.[18] While there were no statistically significant differences, the time required to
complete tasks was generally shorter with the customized joysticks. In some cases,
there was an improvement in the PIDA scores, indicating better driving performance.
The National Aeronautics and Space Administration-Task Load Index assessment indicated
reduced workload and improved performance for all patients after using the customized
joysticks. Patients reported lower mental and physical demands, reduced effort, and
lower frustration levels. Psychosocial Impact of Assistive Devices Scale was used
to evaluate the impact of the customized joysticks on patients' subjective well-being.
The results showed positive scores in all subscales (competence, adaptability, self-esteem),
indicating that using the customized joysticks did not negatively affect patients'
well-being. Instead, it led to increased self-efficacy and decreased negative emotional
reactions to disability. The study suggests that the customized joysticks significantly
improved the driving abilities and user satisfaction of patients with severe upper
extremity disabilities. While not all improvements reached statistical significance,
the qualitative improvement in patients' well-being and driving performance was evident.
There was improvement of 3D-printed cage procedure in patients who underwent ACDF.[20] According to Odom's criteria for neurological function, there was a significant
improvement at 6 months after the operation and at the last follow-up compared with
before the operation. The Japanese Orthopaedic Association score, which assesses the
severity of myelopathy and neurological function, improved significantly. The study
reports that all patients experienced significant improvement in their symptoms of
cervical spondylosis. Specific symptoms are not detailed, but patients' overall conditions
improved. The study indicates that the cervical curvature index improved significantly
from the preoperative value. The curvature of the cervical spine was restored, which
is important for maintaining proper spinal alignment and function. Height of the intervertebral
space between the cervical vertebrae improved significantly, indicating that the procedure
helped restore and preserve intervertebral height. The study concludes that the application
of 3D-printed cages in ACDF is safe and stable. The cage fusion rate was 100% at the
6-month and last follow-ups, indicating that the 3D-printed cages effectively promoted
vertebral fusion.
Patients who received CBT screws for posterior lumbar fusion reported preoperative
symptoms, which included pain (100% of patients), sensory involvement (66.8%), weakness
(29.1%), and incontinence/impotence (2.5%).[16] The study measured improvement using the VAS for pain and the Oswestry Disability
Index (ODI) to assess disability. The mean preoperative VAS score for pain was 8.2,
and the mean preoperative ODI was 59.6. At the 1-month follow-up, the mean VAS score
for pain improved to 3.8, and the mean ODI improved to 27.4. At the last follow-up
(mean follow-up of 32.3 months), the mean VAS score for pain further improved to 2.7,
and the mean ODI improved to 16.7. In patients with a follow-up longer than 24 months
(53.4% of patients), fusion was obtained in 92.4% of cases. The study also compared
different groups based on patient characteristics, procedural time, and other factors.
The groups were divided into group 1, group 2, and group 3. Group 1 had a mean age
of 47.5 years, group 2 had a mean age of 58.6 years, and group 3 had a mean age of
57.9 years. The procedural time was 187 minutes for group 1, 142 minutes for group
2, and 124 minutes for group 3. The groups showed differences in procedural time,
age, X-ray dose, and hospital stay. Complications were also compared among the groups,
with group 1 having a higher complication rate (16.3%) compared with group 2 (3.8%)
and group 3 (0.0%). The study suggests that there is a learning curve for surgeons
in adopting the CBT technique. As surgeons gained more experience with the technique,
procedural times improved, and the accuracy of screw placement increased. The reduction
in complications over time may be attributed to the learning curve as surgeons became
more proficient in performing CBT procedures.
The 3DP group had a shorter operation time, with a mean operation time of 8.1 hours.[2] The control group (titanium cage group) had a longer operation time, with a mean
operation time of 9.1 hours. The 3DP group had less intraoperative blood loss, with
a mean blood loss of 1614.3 mL. The control group (titanium cage group) had greater
intraoperative blood loss, with a mean blood loss of 1850.5 mL. Preoperative VAS scores
were similar between the two groups. VAS scores 24 hours postoperative were slightly
lower in the 3DP group (4.9) compared with the titanium cage group (5.4). At 3 months
postoperative, the 3DP group showed a significant improvement in pain relief with
a VAS score of 3.3 compared with the control group. One year postoperative, the 3DP
group maintained better pain relief with a VAS score of 2.1 compared with the control
group. The 3DP group had a fusion time of 12.5 months, which was slightly longer than
the titanium cage group (10.9 months). Implant subsidence was significantly lower
in the 3DP group (1.8 mm) compared with the titanium cage group (5.2 mm).
Preoperative local lordotic angles were not significantly different between the 3DTi
and sPEEK cage groups.[15] At 3 months postoperatively, the local lordotic angles in the 3DTi group were significantly
improved and better maintained compared with the sPEEK group. VEC is a condition where
there is an inward, concave deformation of the vertebral endplates. The study reported
that VEC was observed in a significantly lower percentage of levels in the 3DTi cage
group compared with the sPEEK group. Furthermore, at 3 months postoperatively, no
progression of VEC was seen in the 3DTi group, while 21% of levels in the sPEEK group
showed VEC progression.
Complications
In patients with symptomatic metastatic epidural spinal cord compression of the posterior
column, 3 patients in the simulated group experienced dural damage or cerebrospinal
fluid leakage during surgery.[10] In contrast, 11 patients in the nonsimulated group had these complications.
In adult patients with lumbar degenerative disease or deformity who underwent transforaminal
lumbar interbody fusion or lateral lumbar interbody fusion surgery with SiCaP-packed
3D-printed lamellar titanium cages reported a low rate of complications, with 9.7%
of patients experiencing complications.[21] These complications included revisions to S1 screws, cage subsidence, fractures,
segmental bleeding, chest infection, deep vein thrombosis, superficial wound infection,
and increased leg pain. It is important to note that none of these complications were
directly related to the inserted cages or SiCaP, indicating that the use of 3D-printed
lamellar titanium cages and SiCaP bone grafts did not lead to additional safety risks.
In adult patients with degenerative lumbar spine disorder who underwent lumbar fusion
with CBT screws and interbody fusion, the study reports that the total rate of complications
was 4.2%, with complications decreasing as the surgical team gained experience with
the CBT technique.[16] The most common complications included misplaced screws requiring delayed repositioning,
cage dislocation requiring repositioning, wound infections, and incidental durotomy
(tearing of the dura mater). There were no reports of neurologic deficits. The accuracy
of screw placement was assessed using the Raley pedicle break classification, and
most screws (78.9–93.9%) were classified as grade 0, indicating good placement.
Twenty patients with thoracolumbar metastases underwent en bloc resection and reconstruction
with either 3D-printed autostable artificial vertebrae or titanium cages.[17] Fewer complications were noted in the 3DP group compared with the titanium cage
group. Specific complications mentioned included nerve paralysis, lower limb weakness,
hypoesthesia, cerebrospinal fluid leakage, and infection.
Cage subsidence, a condition where the cage sinks into the vertebral body, was less
common with 3DTi cages.[15] The sPEEK cages exhibited more cage subsidence at 3 months postoperatively. The
study reported a lower occurrence of complications with 3DTi cages. Complications
were primarily observed in the sPEEK cage group.
Limitations
The application of 3DP in medical contexts presents certain limitations. The cost
of 3DP, which is often not covered by national health insurance, can restrict access
to patients who face financial constraints.[14] Additionally, due to the limited availability of 3DP technology in some hospitals,
third-party involvement may be required, potentially complicating communication between
health care providers and patients, and leading to issues of patient mistrust.
It is a relatively expensive approach, with an average cost of approximately $2,500.[20] The administration of the test is time-consuming, taking more than an hour, and
demands extensive training for correct execution. There is also a concern that if
the assessment is not employed consistently over time, the reliability of the test
may be compromised.
The study's relatively small sample may constrain the generalizability of findings.[18] Furthermore, the use of different assessment designs for various tests could impact
comparability between assessments, limiting the depth of insights.
The retrospective nature of the study places constraints on the significance level
of the results.[16] The study's ability to provide comprehensive data on patient-matched 3D-printed
guides for the comparison of homogeneous subgroups with substantial sample size is
hindered.
Segi et al offer several study limitations to consider.[15] It was not conducted as a RCT, and the surgical procedure and fusion range were
based on surgeon preferences. The relatively short follow-up period, although attributed
to the novelty of 3DTi cages, limits the study's ability to capture long-term changes.
The study population's heterogeneity, the absence of patient-reported outcomes, and
potential measurement errors in assessing alignment, VEC, and cage subsidence in radiographs
and CT images should also be acknowledged.
Clinical Implications
The clinical implications of these studies demonstrate the remarkable potential of
3DP technology in enhancing patient outcomes across a range of medical conditions.
From improving hand function for C-SCI patients to streamlining surgical procedures
for metastatic spinal cord compression, 3DP offers a promising avenue for health care
advancement. Furthermore, the reliability of 3D-printed assessments in evaluating
motor function and the creation of customized aids for mobility significantly contribute
to patient well-being. These findings underscore the importance of incorporating 3DP
into clinical practice, offering cost-effective, customized solutions that can enhance
patient independence, reduce complications, and ultimately improve their overall quality
of life.
Conclusion
The current literature reflects favorable outcomes from the application of 3DP technologies
in the treatment of SCIs, with minimal adverse effects. This heralds a new era in
both surgical and nonsurgical interventions for SCIs, offering improved precision
and a diverse array of treatment options for more comprehensive patient care.