Abstract
Aims & objectives
This study evaluates the feasibility and clinical outcomes of using 3D-printed polyetheretherketone (PEEK) patient-specific implants (PSI) for vertebral body replacement (VBR) in patients with spinal tumors. The research question focuses on postoperative results, implant integration, and complications over a 12-month period.
Methods
A single-center, retrospective case series analyzed five patients who underwent spinal reconstruction after tumor resection using PEEK 3D VBR between April 2022 and June 2023. Inclusion criteria were thoracic/lumbar spinal tumors, tumor resection with PEEK 3D VBR reconstruction, and follow-up exceeding 12 months. PEEK implants were created using fused filament fabrication from medical-grade PEEK. Patient data included demographics, medical history, tumor characteristics, and surgical outcomes. Radiological evaluations assessed bony fusion, local angle changes, and segment height stability. Descriptive statistical analyses were performed using R software.
Results
The mean follow-up duration was 19.2 months. All patients remained alive, with one experiencing local recurrence. Postoperative imaging showed a decrease in local angle with no significant changes during follow-up. Segment heights remained stable, and no PEEK 3D VBR subsidence or hardware failure was observed. Bony fusion was observed in all patients.
Conclusions
The use of PEEK 3D printed PSI for VBR in spinal tumor patients demonstrates promising feasibility and clinical outcomes, with stable implant integration and minimal complications over a 12-month period. Further studies with larger cohorts are recommended to validate these findings.
Keywords: Spine, Tumors, 3D printing, PEEK implants, Custom implants, Patients-specific implants
Highlights
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3D-printed PEEK implants improve spinal tumor surgery outcomes and patient recovery.
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Patient-specific PEEK implants offer a precise fit for vertebral body reconstruction.
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Radiolucent PEEK implants allow better postoperative imaging with minimal artifacts.
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Stable spinal implant integration observed with no subsidence or hardware failure.
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Innovative use of fused filament 3D printing produces durable and customizable implants.
1. Introduction
Options for anterior column reconstruction after tumor resection that have been described in the literature include autografts, allografts, and various materials such as titanium, tantalum, polymethylmethacrylate, and polyetheretherketone (PEEK).1 PEEK is increasingly favored for such reconstructions due to its biocompatibility, radiolucency, and mechanical properties that closely match human bone.2 The advent of 3D printing, particularly fused filament fabrication (FFF), allows for the production of PEEK patient-specific implants (PSI).3 This report aims to evaluate the feasibility and clinical outcomes of using PEEK 3D PSI for vertebral body replacement (VBR) in patients with spinal tumors. It focuses on postoperative results, implant integration, and complications observed over a 12-month period in an initial patient series.
2. Methods
2.1. Study design
This single-center, retrospective case series analyzed consecutive patients undergoing 3D spinal reconstruction after tumor resection at a single tertiary care tumor hospital from April 1, 2022, to June 30, 2023. Inclusion criteria: (1) thoracic/lumbar spinal tumors (benign Enneking S3, primary malignant, or solitary metastatic); (2) tumor resection and reconstruction using PEEK 3D VBR, (3) follow-up exceeding 12 months. All participants provided informed consent, and the study was approved by the Institutional Review Board.
2.2. Setting
The material composition of our PEEK 3D VBR was medical-grade implantable PEEK biomaterial Evonik Vestakeep (Evonik Industries AG, Germany). We preferred PEEK for the implant because it has the following properties: (1) radiolucency allows to achieve minimal artifacts on postoperative MRI/CT scan, (2) minimal interference with radiation therapy planning and delivery, (3) the elastic modulus is close to bone.4 The manufacturing process for PEEK 3D VBR began with extracting CT scan data in DICOM format. The scans encompassed at least one vertebra above and below the affected area. A CT scanning layer thickness of <1 mm was utilized. BonaPlanner software (Bonabyte, Moscow, Russia) was used for 3D imaging reconstruction, further processing, design, and construction of PSI. Bone structures, tumor masses, as well as implants in case of revision surgery were visually displayed. The design of each PEEK 3D VBR was performed considering the surgeon's implant pathway, patient-specific features, and internal fixation method. The body of the PEEK 3D VBR had bone graft compartments. The angle between the upper and lower ends of the implant was adapted to accommodate the intended resection and any planned correction of local kyphosis. The endplates of the PEEK 3D VBR were designed to match the shape of adjacent vertebral endplates or osteotomy edges. The fixation structures were designed to improve primary stability and included screw holes or inner screw trajectories for connection to the adjacent vertebrae or a posterior fixation system per patient-specific needs. The final data sets were converted and exported as an STL file and sent to the 3D printer Apium P220 (Apium Additive Technologies GmbH, Karlsruhe, Germany), which finally fabricated the PEEK 3D VBR by the fused filament fabrication method. We used the 3D printing process for PEEK implants described by Honigmann et al..5 Horizontal layer orientation was used, with a layer thickness of 0.4 mm. The extruder temperature was set at 485 °C. Each PEEK 3D VBR underwent rigorous quality control checks to ensure structural integrity and dimensional accuracy.
2.3. Variables/statistical method
Data collection included patient demographics, medical history, tumor characteristics, and surgical outcomes. Radiological evaluation utilized: (1) Brantigan-Steffee classification for anterior bony fusion; (2) Schnake et al.6 method for local angle and progressive angulation; (3) segment height measurement: mean of the distances between the anterior and posterior edges of cranial and caudal endplates. Subsidence was defined as >3 mm loss in segment height compared to postoperative measurement. Descriptive statistical analyses were performed using R software.
3. Results
The study included five patients: three males and two females (Fig. 1, Fig. 2, Fig. 3, Fig. 4, Fig. 5). The mean age was 51.2 years (range: 44–58 years). Four patients presented with primary spinal tumors, while one had a metastatic spinal tumor. Three patients had previous surgeries, while two underwent primary surgery (Table 1). Resection types included three en bloc (two intralesional, one marginal) and one intralesional excision. Three patients underwent a posterior-only approach with additional rods and fixation of the PEEK 3D VBR to the pedicle fixation system. The other two patients had a staged posterior-anterior approach with fixation of the PEEK 3D VBR to adjacent vertebrae.
Fig. 1.
Case 1: A 56-year-old male with a history of laminectomy and subsequent spondylectomy at T7. (a, b) Axial and sagittal MRI of recurrent chondrosarcoma at T8. (c) Preoperative virtual model. (d) The planned surgical intervention involved a wide-margin resection of the tumor. (e) The implant's central part incorporated diagonal 5.4 mm channels to accommodate linked pedicle screws. (f) The PEEK 3D VBR implant used in the surgery featured upper and lower interfaces with 10 mm deep cavities for bone grafting. (g) These surfaces were tailored to match the resection margins, aligned with screws placed in the T6 and T9 vertebrae. (h) Resected specimen. (i) During reconstruction, it was discovered that the posterior superior edge of the implant protruded excessively. This protruding edge was modified intraoperatively using bone rongeurs. The PEEK 3D VBR was implanted. (j) Postoperative 3D reconstruction imaging. (k) CT confirmed implant stability and alignment. (l) Postoperative MRI. (m) A 12-month follow-up CT scan showed a stable implant. (n) A 12-month follow-up MRI. (o) An 18-month follow-up MRI showed local recurrence at the WBB D4 zone.
Fig. 2.
Case 2: A 48-year-old male presented with a T11 osteoblastoma. (a) Preoperative sagittal CT. (b) Preoperative virtual model. (c, d) The PEEK 3D VBR was tailored in size and shape to match the planned defect resulting from the T11 vertebral body resection and featured flanges for fixation to adjacent vertebral bodies using screws. (e) Final implant. (f) Intraoperative image of the implant placement (lateral approach). (g) Postoperative X-ray. (h) Postoperative 3D reconstruction imaging. (i) A 12-month follow-up CT scan showed bone integration at the site of the PEEK 3D VBR. (j) A 12-month follow-up MRI.
Fig. 3.
Case 3: A 60-year-old male with treated thyroid cancer presented with a solitary T7-T9 lesion, including a T8 pathological fracture causing spinal cord compression. (a) Axial MRI at T8. (b) Preoperative sagittal CT showing lytic defect. (c) Preoperative virtual model with the tumor. (d) A PEEK 3D VBR was prepared, which was 10 mm shorter than the planned defect. The upper and lower interfaces of the PSI had 10 mm cavities for bone grafts. They were angulated for correction of kyphotic deformity and adapted to the endplates of adjacent vertebrae. (e) The central part of the implant had 5.4 mm diagonal through-channels to connect with the posterior pedicle fixation system. The lateral edges of the implant had projections for retention during insertion. (f) During the operation, due to spinal shortening and dura mater deformation, the PSI was fixed to the posterior structure with only one of the planned screws. (g) Postoperative 3D reconstruction imaging. (h) Postoperative CT scan showed local kyphosis correction. (i) A 12-month follow-up MRI. (j) A 12-month follow-up CT. PSI was assessed as stable.
Fig. 4.
Case 4: A 42-year-old female with a giant cell tumor in the L3. (a) Axial CT scan. (b) A posterior approach surgery was performed, involving percutaneous pedicle screw fixation of L1-L5 and laminectomy of L3. (c) Virtual simulation of tumor resection with planned 2 mm distraction of the intervertebral space for a tight fit of the PSI. (d) The PEEK 3D VBR had two flanges for screw fixation to the adjacent vertebrae. (e) Congruence of the surface of the final implant and adjacent vertebra. (f) During the insertion of the implant, a metal impactor was used. After striking the impactor with a hammer near the upper flange, the flange fractured. The PEEK 3D VBR, owing to its custom shape, was tightly fitted into the intervertebral space. (g) Postoperative X-ray. The implant was fixed through the lower flange. (h) Postoperative CT scan. (i) A 12-month follow-up MRI. (j) A 12-month follow-up CT scan showed ossification around the PSI.
Fig. 5.
Case 5: A 59-year-old woman with a history of multiple osteochondromas, prior laminectomy, and intralesional resection at the T5-6 level for chondrosarcoma. (a) Axial MRI of recurrent chondrosarcoma at T5. (b) Preoperative sagittal CT showing kyphotic deformity. (c) Virtual simulation of implant placement with deformity correction. (d) The PEEK 3D VBR had patient-specific contact surfaces. (e) The PSI had flanges with holes for pedicle screw fixation on the left side. On the right side, the implant had a 5.4 mm channel for fixation to the posterior metal construct using a screw. (f) Final PSI with models of adjacent vertebrae. (g) Intraoperative image of the implant placement. (h) Postoperative CT reconstruction. (i) Postoperative CT scan. (j) A 12-month follow-up CT scan showed a stable implant.
Table 1.
Clinical data.
| Case | Patient 1 | Patient 2 | Patient 3 | Patient 4 | Patient 5 |
|---|---|---|---|---|---|
| Gender | Male | Male | Male | Female | Female |
| Age (years) | 56 | 48 | 60 | 42 | 59 |
| Tumor Type | Chondrosarcoma, T7-T8 | Osteoblastoma, T11 | Solitary thyroid metastasis, T7-9 | Giant cell tumor, L3 | Chondrosarcoma, T5-6 |
| Previous treatment details | Laminectomy, revision spondylectomy | Open biopsy, laminectomy | Thyroidectomy, radioiodine therapy | No | Laminectomy, intralesional resection |
| WBB Classification | 2-8, C-D | 2-11, A-C | 4-8, A-D | 6-8, A-C | 4-8, B-D |
| Preoperative neurological status | ASIA C, non-ambulatory | ASIA E, walk independently | ASIA D, walk with assistance | ASIA E, walk independently | ASIA C, non-ambulatory |
| Resection | En bloc (intralesional) | Intralesional excision | En bloc (intralesional) | En bloc (marginal) | En bloc (intralesional) |
| Fixation levels | T5-T11 | T9-L1 | T4-T12 | L1-L5 | T3-T9 |
| Intraoperative Blood Loss (mL) | 700 | 600 | 2250 | 700 + 300a | 1000 |
| Postoperative Complications | CSF Leak | None | None | None | CSF Leak, Hydrothorax |
| Adjuvant treatment after surgery | SBRT 30 Gy 3 in fractions | No | SBRT 27 Gy in 3 fractions | No | SBRT 30 Gy in 3 fractions |
| Follow-up time (months) | 28 | 20 | 19 | 17 | 12 |
| Ambulatory status at follow-up | Walk independently | Walk independently | Walk independently | Walk independently | Walk with assistance |
| Local recurrence/treatment | 18 months/proton therapy | No | No | No | No |
Posterior and anterior stages of surgery.
The mean follow-up duration was 19.2 months (range: 12–28 months). During the follow-up period, all patients remained alive. Three patients received postoperative radiotherapy as part of local treatment. One patient experienced local recurrence during the follow-up period. Postoperative imaging demonstrated a decrease in the local angle, with no significant changes observed during the follow-up period (Table 2). Segment heights remained stable across all patients (Fig. 6). No PEEK 3D VBR subsidence or hardware failure was observed during the follow-up period. Based on the Brantigan-Steffee classification, two patients achieved Grade 4 (probable radiographic fusion), and three patients achieved Grade 5 (solid radiographic fusion).
Tabel 2.
Radiological data.
| Case | Patient 1 | Patient 2 | Patient 3 | Patient 4 | Patient 5 |
|---|---|---|---|---|---|
| Local angle, degrees | |||||
| Preoperative | 30 | 14 | 31 | −27 | 33 |
| Postoperative | 20 | 12 | 19 | −33 | 15 |
| Follow-up | 20 | 13 | 20 | −35 | 17 |
| VBR implant angulation, degrees | |||||
| Postoperative | 85 | 93 | 83 | 122 | 88 |
| Follow-up | 84 | 92 | 81 | 121 | 87 |
| Segment height, mm | |||||
| Preoperative | 90.5 | 66 | 107.5 | 99.5 | 79 |
| Postoperative | 91 | 66.5 | 101 | 92.5 | 78.5 |
| Follow-up | 89.5 | 66.5 | 100 | 92.5 | 78 |
| Brantigan-Steffe at follow-up, grade | 5 | 5 | 4 | 5 | 4 |
Fig. 6.
Radiological measurements. (a) Local angle. (b) Segment height difference.None.
4. Discussion
This study aimed to evaluate the clinical outcomes of PEEK 3D VBR for reconstruction in patients with spinal tumors. Our findings indicate several advantages of these implants, including precise anatomical fit, potential for osseointegration, and improved postoperative imaging due to PEEK's radiolucency. All patients demonstrated satisfactory outcomes with stable implant integration over a 12-month follow-up period.
Mechanical stability is fundamental for implant effectiveness. Literature supports that FFF PEEK can meet physiological load-bearing demands.2 Limaye et al. reported mechanical properties comparable to cortical bone,7 while Basgul et al. demonstrated that 3D-printed PEEK lumbar cages meet requirements for intervertebral devices.8 Long-term fatigue resistance is vital for implants under cyclic loading. Rendas et al. highlighted that 3D-printed PEEK's semi-crystalline nature enhances fatigue behavior, with a fatigue strength of 65 MPa.9 Build orientation also impacts mechanical properties. Rahman et al. showed that 0-degree layer orientation provides higher strength.10 In our study, we used horizontal layer orientation to optimize load-bearing capacity. Despite these advantages, an intraoperative breakage incident in Case 4 highlighted the vulnerability of interlayer adhesion under high-impact forces. To mitigate such risks, we recommend either reinforcing the flanges by increasing their thickness or eliminating them altogether. Instead, channels for fixation may be formed through the implant body.
PEEK's biocompatibility and inert nature prevent adverse tissue reactions, but hinder bone attachment. To address this, our PEEK 3D VBRs incorporate compartments for bone grafting, promoting osseointegration. Postoperative imaging showed successful integration, with all patients exhibiting probable or solid radiographic fusion per Brantigan-Steffee classification. While 3D-printed titanium implants use porous edges for osseointegration,11 PEEK implants rely on bone grafting. Titanium may offer better stability for extended defects12; however, three out of five patients with multilevel defects in our study showed no instability after PEEK 3D VBR reconstruction. PEEK's elastic modulus (3.84 GPa) closely matches cancellous (3.78 GPa) and cortical bone (14.64 GPa), significantly lower than titanium (110 GPa).13,14 This reduces stress shielding and enhances osseointegration, particularly when the implant rests on cancellous bone.
Virtual simulation using CT and MRI enhances preoperative planning, improving resection and reconstruction accuracy.15 In Case 5, it aided implant endplate angulation for deformity correction and guided screw placement. PSI offers sophisticated reconstruction capabilities, connecting VBRs to posterior fixation rods and using flanges for lateral fixation. This is particularly beneficial for extensive vertebral defects or multilevel resections.16 However, reliance on a preoperative plan and PSI can pose challenges. Unforeseen intraoperative factors, including unexpected tumor growth, accidental excessive bone removal, or underestimated anatomical variations, may render the PSI unsuitable. In our study, only one implant option was used, lacking variations in size. In Case 1, we had to modify the implant during surgery due to a planning error. Typically, titanium PSIs are available in multiple sizes during surgery. Several authors have employed PSI in 2–3 mm increments,17,18 although even this approach does not entirely eliminate the risk of unsuccessful implantation.19 In Case 3, spinal shortening caused deformation of the dura mater, preventing placement of a second fixation screw.
Titanium PSIs cause significant CT artifacts, complicating oncological follow-ups and RT planning.20 PEEK's radiolucency offers advantages, allowing unobstructed imaging crucial for RT planning and tumor recurrence detection.21 Our findings support that PEEK 3D VBRs efficiently reduce imaging artifacts, facilitating more precise postoperative evaluations and ongoing monitoring of spinal tumors and bone fusion.
4.1. Limitations & strength
This study has several limitations. First, the small sample size limits the generalizability of our findings. Future studies with larger cohorts are necessary to validate our results. Second, the follow-up duration does not capture long-term complications or implant durability. Longitudinal studies are required to understand the longevity and performance of PEEK 3D VBR. Third, the customization process for each implant is time-consuming and resource-intensive, potentially limiting widespread adoption. Deviations during surgery can render the PSI unsuitable. Fourth, the lack of comparative studies with 3D-printed titanium and standard implants limits our ability to compare the mechanical stability of different implants. Fifth, the current regulatory framework lacks specific guidelines for quality assurance and defect control for PSI, impacting reliability and safety.
5. Conclusion
PEEK 3D VBR represents a viable and innovative approach for reconstruction in patients with spinal tumors. Their ability to provide patient-specific solutions and reduce imaging artifacts marks a significant advancement in spinal surgery. Our study observed satisfactory postoperative outcomes, stable implant integration, and no implant-related complications over 12 months. Continued research and development in this field will be essential to address the current limitations and enhance the clinical application of this promising technology.
CRediT authorship contribution statement
Nikita Zaborovskii: Conceptualization, Supervision, Formal analysis, Writing – original draft. Sergei Masevnin: Investigation, Resources. Oleg Smekalenkov: Investigation, Resources. Vladislav Murakhovsky: Writing – review & editing. Dmitrii Ptashnikov: Writing – review & editing.
Consent to participate
Informed consent was obtained from all individual participants included in the study.
Ethics approval
The study was approved by the Hospital Institutional Review Board and complied with International Ethical Guidelines for Biomedical Research, Declaration of Helsinki, and local laws. Approval was granted by the Institutional Review Board of Vreden National Medical Research Center of Traumatology and Orthopedics (IRB № 003/24-1, 01/24/2022).
Consent for publication
Patients signed informed consent regarding publishing their data and photographs.
Availability of data and material
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Code availability
The R code generated during the current study is available from the corresponding author on reasonable request.
Declaration of generative AI and AI-assisted technologies in the Writing process
During the preparation of this work, the authors used generative AI-assisted technologies to improve the translation of the manuscript into English. After using this tool/service, the authors reviewed and edited the content as needed and take full responsibility for the content of the publication.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
There is no funding source.
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.