Evaluation of 3D-printed Porous titanium alloy versus Polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical degenerative disease

doi:10.21203/rs.3.rs-4931040/v1

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Research Article

Evaluation of 3D-printed Porous titanium alloy versus Polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical degenerative disease

https://doi.org/10.21203/rs.3.rs-4931040/v1

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Study Design

- Single-center retrospective cohort study.

Purpose

- To compare the long-term clinical and radiographic outcomes of patients who have undergone multilevel anterior cervical discectomy and fusion (ACDF) with either 3D-printed titanium (TTN) or polyetheretherketone (PEEK) cages.

Overview of Literature

- ACDF with 3D-printed TTN or polyetheretherketone (PEEK) cages is an effective surgery for patients with cervical radiculopathy/myelopathy. The advent of 3D-printed porous TTN cages and its microporous structure has contributed to diminished subsidence and improved osseointegration compared to PEEK. This study compares the long-term outcomes of both implants among patients who underwent a multi-level ACDF procedure.

Methods

– 96 patients underwent multilevel (2, 3, 4) ACDF surgery, of whom 66 and 30 received a PEEK and 3D-printed TTN interbody cage, respectively. Radiographic outcomes for fusion, cage migration, and subsidence were determined with cervical x-rays and analyzed with independent 2-sample T-test and χ2 test. Visual analog score (VAS) and Neck Disability Index (NDI) score were examined with repeated measure analysis of variance.

Results

- The TTN group reported diminished NDI scores compared to the PEEK group (6.74 ± 5.58 vs 11.29 ± 8.67, p = 0.017) 2 years postoperatively. Furthermore, patients with 3D-printed TTN implants had a significantly shorter duration to fusion at the distal operated level in 3-level ACDF procedures (12.0 ± 5.20 vs 19.1 ± 5.91) (p = .011). The two cohorts reported no statistically significant difference in fusion rates.

Conclusions

– 3D-printed TTN implants enhanced the time to bony fusion at distal levels relative to PEEK cages. Clinically, patients with 3D-printed TTN implants reported diminished NDI scores at 2 years postoperatively. Such findings highlight the difference in outcomes clinically and radiographically for PEEK and 3D-printed TTN implants that need to be considered in optimizing multilevel ACDF procedures.

Cervical Spine

Cervical spondylolitic myelopathy

Multi-level anterior cervical discectomy and fusion

3D-printed Titanium

PEEK

In 1955, Smith and Robinson introduced the anterior cervical discectomy and fusion (ACDF) procedure as a treatment for cervical myelopathy and/or radiculopathy [1]. The surgery utilizes an anterior approach to decompress the spinal cord and neuroforamina, restore physiologic disc height, stabilize vertebral bodies, and help restore lordosis. Initially, tricortical iliac crest bone graft was the gold standard for interbody fusion materials. However, due to donor site complications such as infections, hematomas, and chronic wound pain, interbody devices like cervical polyetheretherketone (PEEK) and 3D-printed titanium (TTN) cages have become more favorable alternatives [2, 3].

PEEK is a thermoplastic polymer material with biocompatibility to the spinal cord and the surrounding anatomy [4, 5]. With an elasticity modulus similar to native bone, it presents a greater pullout resistance than bone, increased centroidal stresses at the spacer-endplate interface, and diminished cage subsidence [6, 7]. Additionally, due to its radiolucency, PEEK cages enable physicians to evaluate bridging trabecular bone postoperatively without radiographic artifacts [8]. However, the implant’s application is limited by a biofilm layer that diminishes the bone-implant interface due to the hydrophobic and low osteogenic nature of the implant [9, 10].

On the other hand, standard titanium cages are associated with restoring lordosis, providing long-term stabilization, and increasing osteogenic and angiogenic factors due to their structural properties [11–13]. Yet, due to a high elasticity modulus, they have also been related to higher rates of subsidence, contributing to inferior clinical outcomes and loss of correction. The increased stress shielding has also led to increased bone resorption and ultimately implant migration [14, 15]. Another downside of titanium is its radio-opacity on CT imaging and X-rays hindering accurate interpretation of bony growth and arthrodesis between the vertebral endplates [16]. However, with the advent of 3D-printed technology, 3D-printed porous titanium cages and its microporous structure has contributed to diminished subsidence compared to PEEK cages [17]. This is primarily attributed to the similarity of the elastic modulus to existing bone due to the degree of porosity. Additionally, the porous and rough scaffold and surface porosity of the 3D-printed TTN cage has shown to improve osseointegration through bony ingrowth and on-growth in in-vivo ovine models [18]. Further studies are necessary to compare the effectiveness of this technology to conventional PEEK cages.

Several studies elucidate the comparison between PEEK and standard TTN cages in ACDF procedures. In a prospective report comparing both implants in 3-level ACDF procedures, Chen et al. revealed that the PEEK implants maintained disk height restoration and cervical lordosis with considerably increased Neck Disability Index (NDI) and Japanese Orthopedic Association (JOA) score relative to the TTN cages [19]. In conjunction, Niu et al. noted PEEK cages were more optimal in maintaining cervical interspace height and radiographic fusion in 1 to 2-level ACDF surgeries [20]. However, a study led by Cabraja et. al found that there was no statistically significant difference in clinical outcomes and fusion rates between both implants following single-level ACDF [21]. Similarly, Li et al. performed a meta-analysis comparing the clinical outcomes of the two implants. They noted that despite a greater rate of subsidence in the TTN group, no statistical significance was indicated in functional and radiographic parameters [22]. Yet, in a study comparing outcomes of patients who underwent an ACDF procedure with PEEK vs 3D-printed TTN implant, the latter cage contributed to improved fusion quality and subsidence severity [23]. However, the study lacked long term outcomes and a sufficient sample size. Additionally, a study by Arts et al. noted that the 3D-printed TTN implant produced a faster fusion rate compared to standard PEEK cages despite no statistical difference in fusion rates and a lack of long-term follow-up [24].

Despite the wide use, there are conflicting findings on the clinical and radiographic outcomes of ACDF procedures with 3D-printed TTN and PEEK implants. Additionally, level-specific rates of arthrodesis and time to fusion are absent and minimal in such studies while assessing multi-level fusion. As such, the lack of conclusive evidence regarding the effectiveness of the different cages and lack of fusion rates by level in 2, 3, and 4 level procedures necessitate the need for further research. This retrospective cohort study aimed to investigate and compare the long term radiographic and clinical outcomes of patients undergoing multi-level ACDF procedures with PEEK vs 3D-printed TTN implants.

Ethics Statement

We conducted this study in compliance with the principles of the Declaration of Helsinki. The study’s protocol was reviewed and approved by the Institutional Review Board of Medical City Plano (IRB No. 2023.019). Informed consent was waived.

Study Design

This is a single-center retrospective cohort study of patients with cervical radiculopathy and/or myelopathy who have undergone multilevel ACDF surgery using either PEEK or 3D-printed TTN cages from 2018-23. All patients met the selection criteria which included: (1) Objective evidence of degenerative disc disease and herniation at more than single contiguous levels between C2 and T1, (2) symptoms of cervical myelopathy and/or radiculopathy resulting from mild spinal cord compression and nerve root impingement, and (3) unresponsive to at least 6 weeks of conservative treatment. Patients who were pregnant or incarcerated were excluded. Patients with previous surgery at adjacent levels were also removed from the study.

Patient Population

All patients ≥ 18 years undergoing multilevel (2, 3, and 4) anterior cervical discectomy and fusion (ACDF) with either PEEK or 3D-printed TTN cages at a single institution during 2018–2023 were retrospectively identified. The requirement for informed consent from individual patients was omitted due to the retrospective design of this study. Approval from the local Institutional Review Board (IRB approval no.1735658-2) was obtained.

Surgery

All patients underwent a modified left Smith-Robinson approach for anterior cervical discectomy and fusion. Patients were placed in a supine position under general anesthesia with the head in slight extension. Subplatysmal dissection was carried out in a transverse fashion. Following appropriate exposure, fluoroscopy confirmed the correct operative level. Caspar pins were inserted for distraction. The annulotomy was completed under a high-magnification microscope. Decompression was completed and PLL was resected. Endplates were decorticated for bleeding subchondral bone. The cage implant was filled with locally harvested autograft and/or allograft (demineralized bone putty) and implanted into the disc space. The position was confirmed by A-P and lateral fluoroscopy. The anterior plate was contoured to physiological curvature and secured in all cases. Patients were instructed to wear a hard cervical collar for 3 months postoperatively.

Clinical and Radiographic Assessments

The patients were dichotomized into two groups based on the use of an implanted interbody cage (PEEK vs 3-D printed TTN). Demographic data collected at baseline included age, smoking status, and osteoporosis. Intraoperative complications and estimated blood loss were recorded from operative notes. Radiographic outcomes including arthrodesis, cage migration, and subsidence were evaluated with flexion/extension cervical x-rays at the 6-month, 1-year, and 2-year postoperative dates for each operated level. Cage subsidence was recorded when the loss of intervertebral height was over 2 mm. Fusion was determined based on less than 2mm of interspinous motion of the adjacent vertebral spinous process to the operated levels and at least 50% trabecular bone bridging at the graft-endplate interface (Fig. 1A-B) (Fig. 2A-B) [25]. All imaging studies were reviewed by a board-certified neuroradiologist blinded to the study objective. Clinical outcomes were collected at baseline and at 6-month, 1-year, and 2-year follow-up visits including visual analog score (VAS) and neck disability index (NDI). Complications including pseudoarthrosis, screw loosening, dysphagia, recurrent laryngeal nerve injury and durotomy were recorded.

Statistical analysis

Clinical outcomes at 6-month, 1-year, and 2-year postoperative dates were analyzed with repeated measure analysis of variance between PEEK and 3D-printed TTN groups. Independent 2-sample T-test analysis or Wilcoxon rank-sum test was used to compare the means of the 2 groups. The Fisher exact test was used to determine an association between the categorical variables. All statistical analyses were performed using SPSS (Ver. 17.0; SPSS Inc, Chicago, IL, USA), with statistical significance set at P value < 0.05.

Of 96 patients that met the inclusion criteria, 66 (69%) patients were in the PEEK group and 30 (31%) were in the 3D-printed TTN group. The mean age of the patient at the time of the surgery was 63.21 years ± 10.59 and 63.32 years ± 12.7 for the PEEK and 3D-printed TTN groups (p = .468). There was no significant difference in the prevalence of osteoporosis (p = .718), smoking (p = .783) preoperative NDI (p = .410), and VAS (p = .737). Intraoperatively, the difference in estimated blood loss (p = .448) and number of levels operated (p = .115) was not significant (Table 1). The ACDF procedures were identified based on the implant and the number of consecutive operated levels (Table 2). Compared to the PEEK implant group, patients with the 3D-printed TTN cage reported decreased VAS scores at the 6 months (2.38 ± 2.50 vs 1.89 ± 2.70), 1 year (1.77 ± 2.02 vs 1.07 ± 2.22) and 2-year (1.63 ± 2.73 vs 1.25 ± 1.42) postoperative dates without significance. Similar trends were described in the NDI scores at the 6-month and 1-year postoperative dates. However, the 3D-printed TTN group presented a significantly decreased NDI score (6.74 ± 5.58 vs 11.29 ± 8.67) (p = 0.017) at the 1-year postoperative visit (Table 3).

In 2-level ACDFs, both groups recognized fusion at all proximal levels. The time to fusion for this level was 11.40 months ± 1.2 in the PEEK group vs 10.5 months ± 4.32 in the 3D-printed TTN group (p = .697). At the caudal level of such procedures, 92.3% and 83.3% fusion were reported for the PEEK and 3D-printed TTN populations. The time to fusion for PEEK and 3D-printed TTN was non-significant (11.53 ± 1.16 vs 11.45 ± 4.02, p = .975) (Table 4).

In 3-level ACDFs, fusion occurred at all proximal levels in the 3D-printed TTN group and 95.5% of the PEEK group. There were no significant differences in postoperative time to fusion. At the 2nd level of 3-level ACDFs, 95.5% and 84.6% fusion were reported for the PEEK and 3D-printed TTN group (p = .539). The PEEK group had a greater time to fusion than the 3D-printed TTN group (11.53 ± 1.16 vs 11.45 ± 4.02) (p = .075). For the distal level, a noticeable decline in fusion rates was observed. 73.9% and 61.5% of the PEEK and 3D-printed TTN implants led to arthrodesis, respectively. Yet, the 3D-printed TTN group had a significantly shorter time till fusion in comparison to the PEEK cages at the distal level of 3-level procedures (12.0 ± 5.20 vs 19.1 ± 5.91) (p = .011) (Table 4).

Lastly, in the 4-level procedures, there was no statistically significant difference in the fusion rates at the proximal, 2nd, and 3rd levels with near 100% arthrodesis in both groups. However, at the caudal (4th) level, the fusion rates for the PEEK and 3D-printed TTN populations were 40% and 50% respectively. Additionally, despite lacking significance, the time to fusion was noticeably greater at caudal levels (Table 4).

There were 17 cases of dysphagia with 10 in the PEEK (15.2%) group and 7 in the 3D-printed TTN group (23.3%). Yet only 1 case in the PEEK group (1.67%) presented dysphagia following the acute 3-month period. One case of durotomy was reported intraoperatively in the PEEK group (1.67%). 5 cases of screw loosening were discovered with 3 in the PEEK group (5.00%) and 2 in the 3D-printed TTN (6.67%). Subsidence was described in 2 patients in the PEEK group (3.33%) and 6 patients in the 3D-printed TTN group (20.0%). Pseudoarthrosis mostly occurred at distal levels for 2, 3, and 4-level procedures. The common intervertebral levels included C6-C7 and C5-C6. Neither of the groups had any occurrence of reoperation or additional surgery (Table 5).

This study aimed to evaluate clinical and radiographic outcomes after multi-level ACDF with either 3D-printed TTN or PEEK cages. Overall, we found the 2 groups had similar demographics and preoperative status. Postoperative outcomes, including VAS scores, NDI scores at the 6-month and 1-year dates, hardware failure, and reports of dysphagia, were similar between the 2 groups. Additionally, there was no significant difference between the overall fusion rates compared to the 3D-printed TTN cages. Results from previous studies with standard TTN and PEEK cages are in alignment with the findings of this study. In a study by Chen et al., the authors discovered no statistical significance in comparing fusion rates between both multi-level constructs [19]. Additionally, despite only evaluating single-level procedures, Cabraja et al. also concluded that there was no difference with 93.2% of the titanium group and 88.1% of the PEEK group reflecting arthrodesis [21]. Similar findings are found in studies employing 3D-printed TTN implants. Arts et al. similarly identify the fusion rates of the PEEK and 3D-TTN groups as 90 and 91%, respectively [24]. In our study, 92% and 86% of the operated levels led to fusion at the 1 and 2-year postoperative dates in the PEEK and 3D-printed TTN groups respectively. As such, both implants are effective in attaining radiographic success following 1 to 2 years postoperatively. Comparable studies have mirrored such findings with 96.3% of TTN and 100% of PEEK cages resulting in fusion at 12 months postoperatively [11, 26]. Lastly, a systematic review of studies comparing 3D-printed TTN and PEEK failed to identify statistical difference in fusion outcomes [27]. However, the included studies with 3D-printed TTN cages lacked long-term efficacy and presented minimal sample sizes demonstrating the need for more comprehensive studies.

The data from our study demonstrated that the 3D-printed TTN implants reached fusion in a significantly shorter duration at the 3rd consecutive operated level for 3-level procedures compared to the PEEK group. As such, the findings may demonstrate the impact of 3D-printed TTN implants in advancing osseointegration at distal levels and maintaining lordosis. Additionally, similar findings were observed at caudal levels in 2 and 4-level procedures. A study by Arts et al. revealed that patients who underwent the ACDF procedure with 3D-printed TTN implant had a faster rate of fusion compared to the PEEK cohort. Yet, the overall fusion rates were similar at the 1-year period [24]. In reports comparing single vs multi-level ACDF procedures, there is a clear increase in the rate of pseudoarthrosis from 10–12% in 1-level surgeries compared to nearly 30–56% in 3-level procedures [28, 29]. Similarly, Chien et al. reported that 2-level ACDF presented increased motion at superior adjacent segments than did single-level ACDF [30]. Regarding level-specific rates of fusion, the caudal level had the highest risk of pseudarthrosis in 2,3 and 4-level surgeries in both groups. Additionally, in the 2 and 3-level surgeries of our study, the distal levels were reported to have increased duration to fusion with both implants without statistical significance. In a study by Wang et al., patients had an extensive follow-up of more than 2 years with every pseudoarthrosis occurring at the distal intervertebral level [31]. This may be attributed to the biomechanical contrast between the mobile, lordotic cervical spine and the relatively immobile thoracic spine at the cervicothoracic junction. The significant instability with the transitional anatomy at the C7-T1 level causes degenerative changes and junctional failure in procedures ending at the C7 vertebral level [32].

Plate fixation may optimize outcomes in multi-level procedures. The additional factor has been noted to reduce pseudoarthrosis and diminish reoperation rates [33]. However, in reports employing autologous bone grafts, fusion rates decreased by 18–82% in 3 to 4-level discectomies despite anterior cervical plate fixation [34]. Due to the nature of this study, however, we cannot accurately determine the effectiveness of employing plate fixation. Yet, the addition of metal plating also contributes to complications like laryngeal nerve injury, dysphagia, hardware failure, and spinal cord injury [35]. With 17 incidences of dysphagia at < 3 months and 1 case lasting > 3 months, the impact of anterior plating, surgical time, and retraction was acute. A prior study by Panchal et al. revealed no difference in postoperative dysphagia for patients who underwent ACDF with anterior cervical plate versus zero-profile stand-alone device [36]. As such, anterior cervical plating may not contribute to postoperative dysphagia outcomes. Additionally, 5 complications of minimal screw pullout were noted out of the 96 cases. However, all patients were asymptomatic and 2 patients in the PEEK group (3.33%) and 6 patients (20%) in the 3D-printed TTN group presented with subsidence at the last postoperative date without statistical difference. However, a study by Singh et al. noted that the 3D-printed TTN cages contributed to significantly diminished subsidence rates compared to PEEK group [17]. Such findings are in contrast with many studies indicating higher subsidence in the standard TTN group. For instance, in a study by Chiang et al., the authors reported that TTN cages led to a substantially greater subsidence rate than PEEK implants (34% vs. 5%) [37]. In contrast, other reports by Yson et al. have demonstrated that the rate of subsidence was not impacted by the employment of either implant or did not correlate with patient outcomes [38]. As such, factors including patient bone mineral density and interface contact between endplate and implant must be examined in conjunction with cage materials to deter complications. While the 3D-printed TTN cage may have contributed to decreased subsidence relative to a standard TTN cage, further studies in multi-level ACDF procedures with long-term outcomes are necessary to determine the impact of the material.

At the 1-year postoperative date, 3D-printed TTN cages presented a more optimal NDI score in comparison to the PEEK cages. Otherwise, the clinical outcomes, VAS and NDI, at all other postoperative visits were not statistically different. This may be attributed to the preservation of cervical lordosis and improved osseointegration with TTN implants. However, such factors were not examined in the current study. Thus, further research is necessary to determine the relationship between osseointegration and lordosis with clinical outcomes. Similarly, studies by Niu et al. and Cabraja et al. failed to reveal statistical differences in clinical outcomes [20, 21]. Chen et al. described that the PEEK cages presented statistically better JOA and NDI scores at the final 7-year follow-up compared to the TTN group [19]. However, in a systematic review of 3D-printed TTN cages vs PEEK cages in 1 to 2-level procedures, the 3D-printed TTN cages contributed to a statistically improved NDI and JOA scores compared to the values in the PEEK cohort [27]. While studies by Niu and Cabraja were primarily single-level ACDF procedures, Chen et al. consisted of 3-level ACDF procedures, corresponding to our current study. According to our results and prior literature, TTN implants may present superior clinical outcomes to PEEK cages at the long-term postoperative dates. However, within the first year postoperatively, both implants reflect no significant difference clinically.

As such, the literature on the clinical and radiographic outcomes of different cage materials continues to be mixed. Further comparison of fusion rates with level-specific examination, subsidence rates, and long-term patient outcomes of ACDF patients with class I and II data are necessary to evaluate such interbody implants. Additionally, there is a paucity in studies comparing 3D-printed TTN implants and PEEK implants in multi-level ACDF procedure over a long-term period [27]. With advancements in implant topography and material development, large RCT prospective studies are essential to identify the best implants for improving fusion rates and diminishing complications.

Limitations of our study include the bias of observer variability and measurement error in the radiographic evaluation of fusion and subsidence. Additionally, because there is no current standardization to assess fusion, comparison across several reports is unfeasible. Other limitations include the retrospective nature of this study and the sample size of PEEK vs TTN implants employed (n = 66 vs. n = 30) that limit the generalizability, validity and reliability of results. Lastly, with minimal 4-level procedures in our current study, further multi-center prospective reports are ultimately necessary to compare PEEK and 3D-printed TTN implants in 4-level constructs. Despite the numerous limitations, this retrospective study presents a valuable opportunity to explore novel research questions comparing the clinical outcomes among patients who underwent a multi-level ACDF procedure.

In patients with multilevel ACDF, 3D-printed TTN implants enhanced the time to bony fusion at distal levels relative to PEEK cages in 3-level procedures. Clinically, the titanium implant contributed to decreased NDI scores with statistical significance at the 1-year mark. This is one of few studies comparing the clinical and radiological outcomes of 3D-printed TTN and PEEK interbody cages in multilevel ACDF procedures with level-specific analysis. Such findings highlight the difference in outcomes clinically and radiographically for PEEK and 3D-printed TTN implants that need to be considered while identifying the most optimal implant for multilevel ACDF procedures.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript

Ethical Approval

Competing Interest

“The authors have no relevant financial or non-financial interests to disclose.”

Author Contributions

All authors contributed to the study’s conception and design. Material preparation, data collection, first draft writing and analysis were performed by T.K. All authors read and approved the final manuscript.

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Tables 1 to 5 are available in the Supplementary Files section.

No competing interests reported.

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Evaluation of 3D-printed Porous titanium alloy versus Polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical degenerative disease

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